125742 45 S211 M5 c4591001 1131 11311301

Document text

Page 1 of 278
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version01 DEC 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495515
Page 2 of 278
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/11/2021
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495516
Page 3 of 278
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Demography
1.Subject ID [11311301]
2.Birth Date: /2007
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0495517
Page 4 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495518
Page 5 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495519
Page 6 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathJan/11/2021
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495520
Page 7 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[allergic rhinitis seasonal]
Start Date: UNK/UNK/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[attention deficit hyperactivity disorder]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[adenoids removed]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495521
Page 8 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[fall off diving board]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[stiches insertion back of head]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495522
Page 9 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495523
Page 10 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/11/2021
2.Weight: [45.5]
3.Unit: kg
4.Height: [161.2]
5.Unit: cm
6.Body Mass Index: [17.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495524
Page 11 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Jan/11/2021
2.Randomization Number: [26309]
3.Randomization Group: [ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495525
Page 12 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/11/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR0F75]
5.bSample ID [BR0F76]
5.cSample ID [BS7XR6]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495526
Page 13 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/11/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9B98]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495527
Page 14 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Jan/11/2021 14:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495528
Page 15 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495529
Page 16 of 278
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495530
Page 17 of 278
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495531
Page 18 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495532
Page 19 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495533
Page 20 of 278
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Feb/5/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495534
Page 21 of 278
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/5/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR0G7Y]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495535
Page 22 of 278
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Feb/5/2021 14:06
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495536
Page 23 of 278
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495537
Page 24 of 278
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495538
Page 25 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495539
Page 26 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495540
Page 27 of 278
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/12/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BTZPYP]
5.bSample ID [BTZPYR]
5.cSample ID [BS2DVM]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495541
Page 28 of 278
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/9/2021
2.Erroneous Visit
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495542
Page 29 of 278
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/9/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BTZR49]
5.bSample ID [BTZR4B]
5.cSample ID [BVTP0G]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495543
Page 30 of 278
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495544
Page 31 of 278
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495545
Page 32 of 278
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495546
Page 33 of 278
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495547
Page 34 of 278
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495548
Page 35 of 278
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495549
Page 36 of 278
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495550
Page 37 of 278
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495551
Page 38 of 278
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495552
Page 39 of 278
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495553
Page 40 of 278
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495554
Page 41 of 278
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495555
Page 42 of 278
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495556
Page 43 of 278
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495557
Page 44 of 278
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495558
Page 45 of 278
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Unplanned Assessments
1.Assessments
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495559
Page 46 of 278
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495560
Page 47 of 278
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 30-Apr-2021 01:41 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495561
Page 48 of 278
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495562
Page 49 of 278
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495563
Page 50 of 278
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495564
Page 51 of 278
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495565
Page 52 of 278
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/25/2021
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495566
Page 53 of 278
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR0F92]
5.bSample ID [BR0F93]
5.cSample ID [BS7XVM]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495567
Page 54 of 278
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9BC5]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495568
Page 55 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/05/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495569
Page 56 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/05/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[Sample was taken for Visit 2 which was done at same visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495570
Page 57 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/22/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK4
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495571
Page 58 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/22/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/22/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR0GDF]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495572
Page 59 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/12/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK6
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495573
Page 60 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/12/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/12/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRR8XB]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495574
Page 61 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 4 -
Unscheduled Visit on Mar/24/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/24/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK8
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495575
Page 62 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 4 -
Unscheduled Visit on Mar/24/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/24/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRR8Z1]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495576
Page 63 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 5 -
Unscheduled Visit on Apr/07/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/7/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK10
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495577
Page 64 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 5 -
Unscheduled Visit on Apr/07/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Apr/7/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRR90L]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495578
Page 65 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 6 -
Unscheduled Visit on Apr/20/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/20/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK12
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495579
Page 66 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 6 -
Unscheduled Visit on Apr/20/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Apr/20/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRR91J]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495580
Page 67 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 7 -
Unscheduled Visit on May/04/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/4/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK14
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495581
Page 68 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 7 -
Unscheduled Visit on May/04/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
May/4/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRR92H]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495582
Page 69 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 8 -
Unscheduled Visit on May/19/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/19/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK16
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495583
Page 70 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 8 -
Unscheduled Visit on May/19/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
May/19/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRR93J]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495584
Page 71 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 9 -
Unscheduled Visit on Jun/01/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/1/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK18
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495585
Page 72 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 9 -
Unscheduled Visit on Jun/01/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jun/1/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRR941]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495586
Page 73 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 10 -
Unscheduled Visit on Jun/11/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/11/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK20
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495587
Page 74 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 10 -
Unscheduled Visit on Jun/11/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jun/11/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRR94M]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495588
Page 75 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 11 -
Unscheduled Visit on Jun/22/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/22/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK22
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495589
Page 76 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 11 -
Unscheduled Visit on Jun/22/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jun/22/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRR958]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495590
Page 77 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 12 -
Unscheduled Visit on Jul/06/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/6/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK24
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495591
Page 78 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 12 -
Unscheduled Visit on Jul/06/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jul/6/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRR95M]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495592
Page 79 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 13 -
Unscheduled Visit on Aug/09/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/9/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK26
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495593
Page 80 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 13 -
Unscheduled Visit on Aug/09/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/9/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRR966]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495594
Page 81 of 278
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/12/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495595
Page 82 of 278
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/18/2021
2.Erroneous Visit
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495596
Page 83 of 278
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495597
Page 84 of 278
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495598
Page 85 of 278
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# CategoryAE Id
entifie
rAdverse
EventStart DateIs the Adverse Ev
ent Still OngoingForm Insta
nce
 1. ADVERS
E EVEN
T 1 sacroiliac
joint pain Jan/15/202
1 UNK:UN
K NO
End Date Time:
Feb/8/2021 UN
K:UNK
 Repeating
Pages
 2. DELETED ADVERS
E EVEN
T 2 broken col
lar bone Feb/19/202
1 UNK:UN
K NO
End Date Time:
Apr/23/2021 U
NK:UNK
 Repeating
Pages
 3. ADVERS
E EVEN
T 3 right clavi
cle fractur
e Feb/19/202
1 11:00 NO
End Date Time:
Apr/23/2021 U
NK:UNK
 Repeating
Pages
 4. ADVERS
E EVEN
T 4 skiing acci
dent Feb/18/202
1 11:00 NO
End Date Time:
Feb/19/2021 U
NK:UNK
 Repeating
Pages
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495599
Page 86 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[sacroiliac joint pain]
4.Start Date Time: Jan/15/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/8/2021 UNK:UNK
6.Toxicity Grade: 2
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495600
Page 87 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[excess exercise]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495601
Page 88 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495602
Page 89 of 278
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[broken collar bone ]
4.Start Date Time: Feb/19/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Apr/23/2021 UNK:UNK
6.Toxicity Grade: 1
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(b) (4)
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[injury]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
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(b) (4)
FDA-CBER-2022-5812-0495604
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
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(b) (4)
FDA-CBER-2022-5812-0495605
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***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[right clavicle fracture]
4.Start Date Time: Feb/19/2021 11:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Apr/23/2021 UNK:UNK
6.Toxicity Grade: 2
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495606
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[skiing accident]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495607
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495608
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***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[skiing accident]
4.Start Date Time: Feb/18/2021 11:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/19/2021 UNK:UNK
6.Toxicity Grade: 2
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495609
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[accident]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495610
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495611
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
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(b) (4)
FDA-CBER-2022-5812-0495612
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495613
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495614
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
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(b) (4)
FDA-CBER-2022-5812-0495616
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495617
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
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(b) (4)
FDA-CBER-2022-5812-0495618
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495619
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495620
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495621
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***Confidential***
 
Header Text: c4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 13-Apr-2021 01:26 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495623
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***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : May/18/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495624
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***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495625
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***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495626
Page 113 of 278
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Mar/12/2021
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495627
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***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495628
Page 115 of 278
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495629
Page 116 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJan-11-2021 16:37:00 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495630
Page 117 of 278
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Aug-09-2021 12:20:22 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Randall Approved Jul-23-2021 13:49:50 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamRandall, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Mar-25-2021 15:09:41 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0495631
Page 118 of 278
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Affidavit:
N/A
William
Randall Approved Mar-23-2021 18:56:25 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamRandall, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495632
Page 119 of 278
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Jan-11-2021
16:36:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
01 DEC 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jan-11-2021
16:36:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495633
Page 120 of 278
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-11-2021
16:36:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Obta
ined
Jan/11/2021Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495634
Page 121 of 278
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Subject ID
Date Location User Value Reason
Jan-11-2021 16:36:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
11311301Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Jan-11-2021 16:35:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
/2007Enrollment Entry
3. Sex:
Date Location User Value Reason
Jan-15-2021
01:49:39
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Jan-14-2021
15:58:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Answered dcf has been
submitted to
impala
Jan-13-2021
01:54:42ACV0PF
EINFP60Query 1: Opened IVRS
Reconciliation:
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495635
Page 122 of 278
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00)
Eastern Time (US &
Canada)00  There is a
mismatch
between the sex
reported in
InForm (Male)
and the sex
report in
IMPALA
(Female). Please
review and
reconcile.
Jan-11-2021
16:36:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jan-11-2021
16:36:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Jan-11-2021
16:36:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
WHITEInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495636
Page 123 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-13-2021
03:05:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Jan-12-2021
09:32:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Answered data updated
Jan-12-2021
05:37:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened DM: Please
update all the
missing pages
under this visit
or else clarify.
Thank you.
Jan-11-2021
16:36:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/11/2021Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495637
Page 124 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Jan-11-2021
16:37:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/11/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-11-2021 16:37:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jan-11-2021
16:37:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495638
Page 125 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.a
Date Location User Value Reason
Jan-12-2021 09:24:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:allergic rhiniti
s seasonal
Start Date: UNK/UNK/2
014
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jan-12-2021 09:24:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-12-2021
09:24:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
allergic rhinitis seasonalInitial Entry
1.a Start Date:
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495639
Page 126 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-12-2021
09:24:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jan-12-2021
09:24:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Jan-12-2021 09:26:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:attention deficit
hyperactivity dis
order
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495640
Page 127 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.b Line/MH Number:
Date Location User Value Reason
Jan-12-2021 09:26:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-12-2021
09:26:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
attention deficit hyperactivit
y disorderInitial Entry
1.b Start Date:
Date Location User Value Reason
Jan-12-2021
09:26:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jan-12-2021
09:26:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
1.c
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495641
Page 128 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-12-2021 09:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:adenoids rem
oved
Start Date: UNK/UNK/2
015
Ongoing: NO
End Date:
UNK/UN
K/2015Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495642
Page 129 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.c Line/MH Number:
Date Location User Value Reason
Jan-12-2021 09:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-12-2021
09:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
adenoids removedInitial Entry
1.c Start Date:
Date Location User Value Reason
Jan-12-2021
09:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Jan-12-2021
09:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495643
Page 130 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.d
Date Location User Value Reason
Jan-12-2021
14:12:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:fall off divin
g board
Start Date: UNK/UNK/
2015
Ongoing: NO
End Date:
UNK/UN
K/2015New
Information
Jan-12-2021
09:28:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:4
Medical
History
Term:fall off diving bo
ard, stiches back
of head
Start Da
te:UNK/UNK/201
5
Ongoing
:NO
End Date:
UNK/UNK/2
015Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495644
Page 131 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.d Line/MH Number:
Date Location User Value Reason
Jan-12-2021 09:28:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-12-2021
16:11:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Jan-12-2021
14:12:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Answered New
Information
Jan-12-2021
14:12:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
fall off diving boardNew
Information
Jan-12-2021
14:04:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.DiscrepPFETMS
OracleQuery 1: Opened Multiple
concepts in the
term FALL OFF
DIVING
BOARD,
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495645
Page 132 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
ancy  STICHES
BACK OF
HEAD. Split the
term into FALL
OFF DIVING
BOARD and
STICHES
INSERTION
BACK OF
HEAD and
submit
separately.
Thank you.
Jan-12-2021
09:28:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
fall off diving board, stiche
s back of headInitial Entry
1.d Start Date:
Date Location User Value Reason
Jan-12-2021
09:28:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Jan-12-2021
09:28:53ACV0PF
EINFP60Data Entry:
NOInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495646
Page 133 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00) Eastern
Time (US & Canada)00  End Date:
UNK/UNK/2015
1.e
Date Location User Value Reason
Jan-12-2021 14:15:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:stiches insertion
back of head
Start Date: UNK/UNK/201
5
Ongoing: NO
End Date:
UNK/UNK/2
015Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495647
Page 134 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.e Line/MH Number:
Date Location User Value Reason
Jan-12-2021 14:15:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-12-2021
14:15:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
stiches insertion back of hea
dInitial Entry
1.e Start Date:
Date Location User Value Reason
Jan-12-2021
14:15:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2015Initial Entry
1.e Ongoing:
Date Location User Value Reason
Jan-12-2021
14:15:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495648
Page 135 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Jan-12-2021
09:29:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
The subject is NOT known t
o be HIV POSITIVEInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495649
Page 136 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-12-2021
09:30:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/11/2021Initial Entry
2. Weight:
Date Location User Value Reason
Jan-12-2021
09:30:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
45.5Initial Entry
3. Unit:
Date Location User Value Reason
Jan-12-2021
09:30:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Jan-12-2021
09:30:05ACV0PF
EINFP60Data Entry:
161.2Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495650
Page 137 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00) Eastern
Time (US & Canada)00 
5. Unit:
Date Location User Value Reason
Jan-12-2021
09:30:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Jan-12-2021 09:30:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
17.5Initial Entry
7.a
Date Location User Value Reason
Jan-12-2021
09:30:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identifi
er::1
Temperature: 36.9
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495651
Page 138 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-12-2021
09:30:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jan-12-2021
09:30:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Jan-12-2021
09:30:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Jan-12-2021
09:30:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495652
Page 139 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Jan-12-2021
09:30:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/11/2021Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jan-12-2021
09:30:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
26309Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495653
Page 140 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-11-2021 17:35:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-11-2021 17:35:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-11-2021
17:35:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-11-2021
17:35:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495654
Page 141 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-11-2021
17:35:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/11/2021Initial Entry
5.a
Date Location User Value Reason
Jan-11-2021
17:35:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR0F75Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-11-2021
17:35:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BR0F75Initial Entry
5.b
Date Location User Value Reason
Jan-11-2021
17:35:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR0F76Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495655
Page 142 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Sample ID
Date Location User Value Reason
Jan-11-2021
17:35:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BR0F76Initial Entry
5.c
Date Location User Value Reason
Jan-11-2021
17:35:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BS7XR6Initial Entry
5.c Sample ID
Date Location User Value Reason
Jan-11-2021
17:35:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BS7XR6Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495656
Page 143 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-11-2021 17:23:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-11-2021 17:23:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-11-2021
17:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-11-2021
17:23:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495657
Page 144 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-11-2021
17:23:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/11/2021Initial Entry
5.a
Date Location User Value Reason
Jan-11-2021
17:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BP9B98Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-11-2021
17:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BP9B98Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495658
Page 145 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-12-2021
09:31:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-12-2021 09:31:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jan-12-2021 09:31:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-12-2021
09:31:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/11/2021 14:50Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495659
Page 146 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5. Anatomical Location:
Date Location User Value Reason
Jan-12-2021 09:31:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-12-2021
09:31:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-12-2021 09:31:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-12-2021 09:31:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495660
Page 147 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-12-2021
09:31:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495661
Page 148 of 278
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Jan-12-2021
09:31:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED F
OR THIS SUBJECTInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495662
Page 149 of 278
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-09-2021
04:52:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PF
EINFP60
00 Query 1: Closed Per site
confirmation_PD
tracker updated
Feb-09-2021
03:33:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PF
EINFP60
00 Query 2: Closed Response satisfies
query
Feb-08-2021
12:55:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PF
EINFP60
00 Query 1: Answere
ddate is correct,
subject and family
were out of town for
2 weeks which fell
during visit 2
window
Feb-08-2021
12:53:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PF
EINFP60
00 Query 2: Answere
dthe date is correct,
subject and family
were out of town for
2 weeks which fell
during visit 2
window
Feb-08-2021
05:09:52
(UTC-05:00)
Eastern TimeACV0PF
EINFP60
00.InFor
mAdapteDMW QUERY Query 2: Opened DMW7171251;The
Date of Visit at Visit
‘V2_VAX2_L’ is not
in chronological
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2022-5812-0495663
Page 150 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(US & Canada) r.Discrep
ancy order based on the
visit schedule.
Please review and
update as
appropriate.
Feb-08-2021
01:06:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy PFE SDQ PROD Query 1: Opened PDQ: Date of visit
at V2_VAX2_L is
out of window for 2
days from
V1_DAY1_VAX1_L
Dose Date. Please
verify and update.
Else, confirm in
query response
appropriately. 
Feb-05-2021
16:45:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/5/2021Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0495664
Page 151 of 278
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FE
V
E
R
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) EasternACV0PF
EINFP60
00 Data Entry:
FEVERInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495665
Page 152 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada)
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495666
Page 153 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495667
Page 154 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HI
LL
S
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:N
OInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495668
Page 155 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495669
Page 156 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495670
Page 157 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.f Symptom:
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495671
Page 158 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.g Symptom:
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED M
USCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT
PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:NOInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495672
Page 159 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.h Symptom:
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495673
Page 160 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.a
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495674
Page 161 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reacti
on::SW
ELL
ING
Were injection site r
eactions present on t
he last day the Subje
ct Diary was complet
ed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495675
Page 162 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Rea
ction::PAIN
AT IN
JECTI
ON SI
TE
Were injection site
reactions present o
n the last day the
Subject Diary was
completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-05-2021
17:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495676
Page 163 of 278
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Feb-05-2021
17:39:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/5/2021Initial Entry
2.a
Date Location User Value Reason
Feb-05-2021
17:39:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identifi
er::1
Temperature: 36.9
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Feb-05-2021
17:39:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
2.a Temperature:
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495677
Page 164 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Feb-05-2021
17:39:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Feb-05-2021
17:39:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Feb-05-2021
17:39:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495678
Page 165 of 278
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-05-2021
16:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-05-2021
16:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-05-2021
16:45:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-05-2021
16:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495679
Page 166 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
correct as
appropriate.
Feb-05-2021
16:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Feb/5/2021Initial Entry
5.a
Date Location User Value Reason
Feb-05-2021
16:45:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR0G7YInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-05-2021
16:45:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BR0G7YInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495680
Page 167 of 278
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-05-2021
17:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-05-2021
17:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Feb-05-2021
17:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-05-2021
17:38:01
(UTC-05:00) EasternACV0PF
EINFP60
00 Data Entry:
Feb/5/2021 14:06Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495681
Page 168 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada)
5. Anatomical Location:
Date Location User Value Reason
Feb-05-2021
17:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-05-2021
17:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-05-2021
17:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-05-2021
17:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495682
Page 169 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-05-2021
17:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495683
Page 170 of 278
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-15-2021
13:36:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Closed Response
satisfies query
Mar-15-2021
13:36:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Mar-15-2021
09:28:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Answered data updated
Mar-15-2021
09:24:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Answered data updated
Mar-15-2021
06:24:29
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Opened DM: The
treatment period
is defined as 1st
vaccination visit
through the
1-month post
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495684
Page 171 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
vaccination visit
after the 2nd
vaccination.
Please complete
treatment
disposition CRF
and update date
of EOT to match
date of visit at
visit 3.
Mar-15-2021
06:23:46
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened DM: Kindly
consider to
update missing
SYMPRDATE
form or else
clarify. Thank
you.
Mar-12-2021
15:47:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Mar/12/2021Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495685
Page 172 of 278
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FE
V
E
R
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) EasternACV0PF
EINFP60
00 Data Entry:
FEVERInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495686
Page 173 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada)
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495687
Page 174 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495688
Page 175 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HI
LL
S
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:N
OInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495689
Page 176 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495690
Page 177 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495691
Page 178 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.f Symptom:
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495692
Page 179 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.g Symptom:
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED M
USCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT
PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:NOInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495693
Page 180 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.h Symptom:
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495694
Page 181 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.a
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495695
Page 182 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reacti
on::SW
ELL
ING
Were injection site r
eactions present on t
he last day the Subje
ct Diary was complet
ed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495696
Page 183 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Rea
ction::PAIN
AT IN
JECTI
ON SI
TE
Were injection site
reactions present o
n the last day the
Subject Diary was
completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-15-2021
09:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495697
Page 184 of 278
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021
15:48:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021
15:48:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021
15:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-12-2021
15:48:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495698
Page 185 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
correct as
appropriate.
Mar-12-2021
15:48:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Mar/12/2021Initial Entry
5.a
Date Location User Value Reason
Mar-12-2021
15:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BTZPYPInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021
15:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BTZPYPInitial Entry
5.b
Date Location User Value Reason
Mar-12-2021
15:48:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BTZPYRInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495699
Page 186 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Sample ID
Date Location User Value Reason
Mar-12-2021
15:48:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BTZPYRInitial Entry
5.c
Date Location User Value Reason
Mar-12-2021
15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BS2DVMInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-12-2021
15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BS2DVMInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495700
Page 187 of 278
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-09-2021
12:26:36
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Aug/9/2021Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495701
Page 188 of 278
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-09-2021
12:28:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-09-2021
12:28:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2021
11:19:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Closed Sent to ICON
for assistance
resolving issue
Aug-25-2021
12:40:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Answered Updated
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495702
Page 189 of 278
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Aug-25-2021
12:04:36
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Reissued:Opened LIMS2: Thank
you for the
response. Please
enter the
barcode under
Sample ID
below.
Aug-25-2021
09:56:57
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Answered BTZR48
belongs to
subject
11311301 and
visit 4
09AUG2021
Aug-24-2021
10:08:05
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Reissued:Opened LIMS1: The lab
did receive
BTZR48 as
well. Please
clarify if
BTZR48
belongs to
another subject
or visit.
Otherwise
please clarify.
Aug-23-2021
11:27:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Answered Wrong bar code
was listed at
first ,updated to
proper bar code
Aug-23-2021
10:55:24ACV0PF
EINFP60Query 2: Opened LIMS: For Visit
5, the lab
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495703
Page 190 of 278
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00)
Eastern Time (US &
Canada)00  received serum
sample barcode
BTZR48;
however, it has
been deleted
below. All
samples
collected and
sent to the lab
(SEND and
RETAIN
samples) must
be recorded.
Please review
and update as
appropriate.
Aug-09-2021
12:28:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-09-2021
12:28:28
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-09-2021
12:28:28
(UTC-05:00)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495704
Page 191 of 278
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Eastern Time (US &
Canada) Aug/9/2021
5.a
Date Location User Value Reason
Aug-09-2021
12:28:56
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BTZR49Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-09-2021
12:28:56
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BTZR49Initial Entry
5.b
Date Location User Value Reason
Aug-20-2021
11:18:01
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BTZR4BChanged
Information
Aug-09-2021
12:29:17
(UTC-05:00)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BTZR48Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495705
Page 192 of 278
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Eastern Time (US &
Canada)
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495706
Page 193 of 278
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Sample ID
Date Location User Value Reason
Aug-23-2021
10:54:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Aug-23-2021
10:24:59
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened LIMS: For Visit
4, the lab
received
BTZR48;
however,
BTZR4B is
recorded. Please
review for
possible data
entry error and
correct if
appropriate.
Otherwise
please clarify.
Aug-20-2021
11:18:01
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BTZR4BChanged
Information
Aug-09-2021
12:29:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BTZR48Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495707
Page 194 of 278
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.c
Date Location User Value Reason
Aug-09-2021
12:29:43
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BVTP0GInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-09-2021
12:29:43
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BVTP0GInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495708
Page 195 of 278
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-26-2021
09:15:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/25/2021Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495709
Page 196 of 278
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-26-2021
09:16:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Obt
ained
Jan/25/2021Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495710
Page 197 of 278
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-26-2021 09:16:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-26-2021 09:16:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021
08:41:05
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-26-2021
09:16:13
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495711
Page 198 of 278
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-26-2021
09:16:13
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/25/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021
08:41:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR0F92Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-27-2021
08:41:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BR0F92Initial Entry
5.b
Date Location User Value Reason
Jan-27-2021
08:41:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR0F93Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495712
Page 199 of 278
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Sample ID
Date Location User Value Reason
Jan-27-2021
08:41:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BR0F93Initial Entry
5.c
Date Location User Value Reason
Jan-27-2021
08:41:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BS7XVMInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-27-2021
08:41:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BS7XVMInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495713
Page 200 of 278
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-26-2021 09:16:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-26-2021 09:16:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021
07:25:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-26-2021
09:16:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495714
Page 201 of 278
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-26-2021
09:16:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/25/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021
07:25:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BP9BC5Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-27-2021
07:25:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BP9BC5Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495715
Page 202 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/05/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-05-2021
16:45:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/5/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-05-2021
16:45:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
SSWAB_WEEK2Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495716
Page 203 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/05/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-05-2021
16:46:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-05-2021
16:46:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-05-2021
16:46:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Feb-05-2021 ACV0PF Data Entry: Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495717
Page 204 of 278
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/05/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
16:46:22
(UTC-05:00) Eastern
Time (US & Canada)EINFP60
00 Sample was taken for Visit 2
which was done at same visi
t
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495718
Page 205 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/22/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-22-2021
11:38:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/22/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-22-2021
11:38:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
SSWAB_WEEK4Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495719
Page 206 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/22/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-22-2021
11:38:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-22-2021
11:38:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-22-2021
12:40:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-22-2021
11:38:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495720
Page 207 of 278
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/22/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Feb-22-2021
11:38:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Feb/22/2021Initial Entry
5.a
Date Location User Value Reason
Feb-22-2021
12:40:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR0GDFInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-22-2021
12:40:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BR0GDFInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495721
Page 208 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/12/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-16-2021
08:50:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Response satisfies
query
Mar-15-2021
09:22:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Answered dates are correct
Mar-15-2021
03:18:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy DMW QUERY Query 1: Opened DMW7698441;The
Date of Visit at
Visit at Visit
‘COVID-19
Surveillance Visit
=
SSWAB_WEEK6’
is the same as the
other Date of Visit
at Visit
‘V3POSTVX2L’.
Please review for
duplication and
update as
appropriate.
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0495722
Page 209 of 278
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/12/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-12-2021
15:19:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Mar/12/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Mar-12-2021
15:19:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
SSWAB_WEEK6Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495723
Page 210 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/12/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021
15:19:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021
15:19:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021
15:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-12-2021
15:19:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495724
Page 211 of 278
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/12/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
correct as
appropriate.
Mar-12-2021
15:19:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Mar/12/2021Initial Entry
5.a
Date Location User Value Reason
Mar-12-2021
15:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRR8XBInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021
15:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BRR8XBInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495725
Page 212 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 4 -
Unscheduled Visit on Mar/24/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-25-2021
15:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Mar/24/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Mar-25-2021
15:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
SSWAB_WEEK8Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495726
Page 213 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 4 -
Unscheduled Visit on Mar/24/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-25-2021
15:10:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-25-2021
15:10:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-25-2021
15:38:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-25-2021
15:10:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495727
Page 214 of 278
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 4 -
Unscheduled Visit on Mar/24/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Mar-25-2021
15:10:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Mar/24/2021Initial Entry
5.a
Date Location User Value Reason
Mar-25-2021
15:38:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRR8Z1Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-25-2021
15:38:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BRR8Z1Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495728
Page 215 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 5 -
Unscheduled Visit on Apr/07/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Apr-07-2021
13:17:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Apr/7/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Apr-07-2021
13:17:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
SSWAB_WEEK10Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495729
Page 216 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 5 -
Unscheduled Visit on Apr/07/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Apr-07-2021
13:17:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Apr-07-2021
13:17:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Apr-07-2021
15:48:46
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Apr-07-2021
13:17:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495730
Page 217 of 278
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 5 -
Unscheduled Visit on Apr/07/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Apr-07-2021
13:17:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Apr/7/2021Initial Entry
5.a
Date Location User Value Reason
Apr-07-2021
15:48:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRR90LInitial Entry
5.a Sample ID
Date Location User Value Reason
Apr-07-2021
15:48:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BRR90LInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495731
Page 218 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 6 -
Unscheduled Visit on Apr/20/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Apr-20-2021
12:58:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Apr/20/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Apr-20-2021
12:58:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
SSWAB_WEEK12Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495732
Page 219 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 6 -
Unscheduled Visit on Apr/20/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Apr-20-2021
12:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Apr-20-2021
12:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Apr-21-2021
08:03:55
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Apr-20-2021
12:58:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495733
Page 220 of 278
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 6 -
Unscheduled Visit on Apr/20/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Apr-20-2021
12:58:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Apr/20/2021Initial Entry
5.a
Date Location User Value Reason
Apr-21-2021
08:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRR91JInitial Entry
5.a Sample ID
Date Location User Value Reason
Apr-21-2021
08:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BRR91JInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495734
Page 221 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 7 -
Unscheduled Visit on May/04/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
May-04-2021
12:44:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
May/4/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
May-04-2021
12:44:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
SSWAB_WEEK14Initial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495735
Page 222 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 7 -
Unscheduled Visit on May/04/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
May-04-2021
12:44:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
May-04-2021
12:44:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
May-04-2021
16:40:58
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
May-04-2021
12:44:34
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0495736
Page 223 of 278
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 7 -
Unscheduled Visit on May/04/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
May-04-2021
12:44:34
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
May/4/2021Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
May-04-2021
16:40:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry: Initial Entry
5.a
Date Location User Value Reason
May-04-2021
16:40:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRR92HInitial Entry
5.a Sample ID
Date Location User Value Reason
May-04-2021
16:40:58
(UTC-05:00) EasternACV0PF
EINFP60
00 Data Entry:
BRR92HInitial Entry
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0495737
Page 224 of 278
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 7 -
Unscheduled Visit on May/04/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada)
090177e19891a040\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0495738
Page 225 of 278
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 8 -
Unscheduled Visit on May/19/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311301 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
May-19-2021
14:07:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
May/19/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
May-19-2021
14:07:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
SSWAB_WEEK16Initial Entry
090177e19891a040\Final\Final 
…[truncated]