125742 S1 M5 CRF c4591001 1171 11711023

Document text

Page 1 of 211
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944579
Page 2 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/13/2020
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944580
Page 3 of 211
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11711023]
2.Birth Date: /1973
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:
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944581
Page 4 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/13/2020
2.Erroneous Visit
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944582
Page 5 of 211
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944583
Page 6 of 211
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944584
Page 7 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hernia Repair]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Foot Toe Surgery]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: UNK/UNK/2000
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Testicular Cancer]
Start Date: Feb/UNK/1998
Ongoing: NO
End Date:
Aug/UNK/1998
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944585
Page 8 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Orchiectomy]
Start Date: Mar/UNK/1998
Ongoing: NO
End Date:
Mar/UNK/1998
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chemotherapy]
Start Date: Apr/UNK/1998
Ongoing: NO
End Date:
Apr/UNK/1998
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Meniscus Tear]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Laparoscopic Surgery]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944586
Page 9 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Modified Krumplit Dissection ]
Start Date: Aug/UNK/1998
Ongoing: NO
End Date:
Aug/UNK/1998
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944587
Page 10 of 211
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/14/2020
2.Weight: [220.0]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [29.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944588
Page 11 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/14/2020
2.Randomization Number: [50045]
3.Randomization Group: [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944589
Page 12 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/14/2020
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 [BP0YSX]
5.bSample ID [BP0YSY]
5.cSample ID [BP0YSZ]
5.dSample ID [BPHHBP]
5.eSample ID [BPHHBR]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944590
Page 13 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/14/2020
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 [BP0Z3B]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944591
Page 14 of 211
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: Aug/14/2020 09:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944592
Page 15 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944593
Page 16 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944594
Page 17 of 211
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
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
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944595
Page 18 of 211
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
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
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944596
Page 19 of 211
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944597
Page 20 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BP0Z8X]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944598
Page 21 of 211
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: Sep/2/2020 09:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944599
Page 22 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944600
Page 23 of 211
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
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
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944601
Page 24 of 211
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
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
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944602
Page 25 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
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 [BP9H1K]
5.bSample ID [BP9H1L]
5.cSample ID [BP9H1M]
5.dSample ID [BRTT90]
5.eSample ID [BRTT91]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944603
Page 26 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944604
Page 27 of 211
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944605
Page 28 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944606
Page 29 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944607
Page 30 of 211
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944608
Page 31 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944609
Page 32 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944610
Page 33 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944611
Page 34 of 211
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944612
Page 35 of 211
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944613
Page 36 of 211
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Sep/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944614
Page 37 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944615
Page 38 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944616
Page 39 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944617
Page 40 of 211
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Ide
ntifierAdverse EventStart Dat
eIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERS
E EVENT 1  Urticaria on forehead, posterior neck, bilatera
l posterior hands and bilateral plantar areas Feb/10/20
21 12:00 NO
End Date Time:
Feb/16/2021 UN
K:UNK
 Repeating
Pages
 2.ADVERS
E EVENT 2  Angioedema - Forehead  Feb/11/20
21 12:00 NO
End Date Time:
Feb/16/2021 UN
K:UNK
 Repeating
Pages
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944618
Page 41 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[Urticaria on forehead, posterior neck, bilateral posterior hands and bilateral
plantar areas]
4.Start Date Time: Feb/10/2021 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/16/2021 UNK:UNK
6.Toxicity Grade: 2
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:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?YES
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944619
Page 42 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944620
Page 43 of 211
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[Angioedema - Forehead]
4.Start Date Time: Feb/11/2021 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/16/2021 UNK:UNK
6.Toxicity Grade: 1
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:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944621
Page 44 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944622
Page 45 of 211
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944623
Page 46 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944624
Page 47 of 211
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944625
Page 48 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: //
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944626
Page 49 of 211
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944627
Page 50 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944628
Page 51 of 211
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944629
Page 52 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944630
Page 53 of 211
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944631
Page 54 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944632
Page 55 of 211
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944633
Page 56 of 211
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944634
Page 57 of 211
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944635
Page 58 of 211
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944636
Page 59 of 211
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944637
Page 60 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944638
Page 61 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 per local/national recommendations and confirmed to have received
only placebo at Vaccination 1 2
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944639
Page 62 of 211
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/4/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944640
Page 63 of 211
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944641
Page 64 of 211
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944642
Page 65 of 211
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944643
Page 66 of 211
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/9/2021
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944644
Page 67 of 211
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944645
Page 68 of 211
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Feb/9/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944646
Page 69 of 211
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/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 [BR2Z94]
5.bSample ID [BR2Z95]
5.cSample ID [BR2Z96]
5.dSample ID [BLG59L]
5.eSample ID [BLG59M]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944647
Page 70 of 211
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/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 [BR2Z93]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944648
Page 71 of 211
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/9/2021 11:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944649
Page 72 of 211
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944650
Page 73 of 211
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944651
Page 74 of 211
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?Not Done Comments
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944652
Page 75 of 211
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944653
Page 76 of 211
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944654
Page 77 of 211
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944655
Page 78 of 211
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944656
Page 79 of 211
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944657
Page 80 of 211
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944658
Page 81 of 211
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Mar/9/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944659
Page 82 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/30/2020
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944660
Page 83 of 211
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944661
Page 84 of 211
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944662
Page 85 of 211
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormAug-14-2020 09:51:58 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944663
Page 86 of 211
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormFeb-12-2021 14:34:14 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944664
Page 87 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-09-2021 16:15:27 (UTC-06:00) Central
Time (US & Canada)Per Investigator, Drug withdrawn due to AE.
Visit 102 Not Done as of right now. CRA was
notified about this and pending clarification on
what to do next.
Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944665
Page 88 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-10-2021 09:54:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944666
Page 89 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-10-2021 09:54:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944667
Page 90 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Mar-10-2021 09:54:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944668
Page 91 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Mar-10-2021 09:54:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944669
Page 92 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Mar-10-2021 09:54:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944670
Page 93 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-11-2021 11:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944671
Page 94 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-11-2021 11:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
1Mar-09-2021 16:16:25 (UTC-06:00) Central
Time (US & Canada)Visit not done.
Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944672
Page 95 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Mar-11-2021 11:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944673
Page 96 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Mar-11-2021 11:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944674
Page 97 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Mar-11-2021 11:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
4Mar-09-2021 16:17:39 (UTC-06:00) Central
Time (US & Canada)Visit not done.
Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944675
Page 98 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Mar-11-2021 11:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944676
Page 99 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Mar-11-2021 11:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
6Mar-09-2021 16:17:58 (UTC-06:00) Central
Time (US & Canada)Visit not done.
Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944677
Page 100 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
7Mar-11-2021 11:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944678
Page 101 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
8Mar-11-2021 11:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944679
Page 102 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
9Mar-11-2021 11:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944680
Page 103 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
10Mar-11-2021 11:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944681
Page 104 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
11Mar-11-2021 11:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
11Mar-09-2021 16:18:14 (UTC-06:00) Central
Time (US & Canada)Visit not done.
Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944682
Page 105 of 211
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 Mar-08-2021 15:33:44 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Earl Martin  Approved Mar-03-2021 10:55:26 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EarlMartin, 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 Feb-08-2021 10:48:24 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Earl Martin  Approved Oct-06-2020 16:53:09 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EarlMartin, 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.
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944683
Page 106 of 211
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Mueed Bari  N/A Sep-18-2020 10:22:19 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Earl Martin  Approved Sep-14-2020 10:25:46 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EarlMartin, 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.
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944684
Page 107 of 211
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-14-2020 09:49:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-14-2020 09:49:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944685
Page 108 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-14-2020 09:49:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/13/2020Transcription Error
Aug-14-2020 09:49:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/14/2020Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944686
Page 109 of 211
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-14-2020 09:49:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11711023Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-14-2020 09:48:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1973Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-14-2020 09:50:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-14-2020 09:50:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-14-2020 09:50:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
WHITEInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944687
Page 110 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-19-2020 15:27:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-19-2020 10:43:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Query 1: Answered Original value is
correct
Aug-19-2020 10:36:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened GPD_Clin: Date of
Visit is
13AUG2020.
However, Vaccine
was given
14AUG2020 when
the dates should
match. Please
reconcile DATES
and update the CRF
as appropriate.
Aug-14-2020 09:51:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Aug/13/2020Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944688
Page 111 of 211
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-12-2020 00:01:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Date of
Completion/Discontinuation
/Death updated to 13/Aug
/2020.
Sep-11-2020 23:10:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-11-2020 23:10:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/13/2020Transcription Error
Sep-11-2020 22:53:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Erica Weaver Query 1: Opened *DM: Please confirm date
as DOV was on 13/Aug,
please correct if necessary.
Thank you.
Aug-14-2020
09:52:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Aug/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-14-2020 09:52:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-14-2020 09:52:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
COMPLETEDInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944689
Page 112 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Aug-14-2020 09:59:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Hernia Repair
Start Date: UNK/UNK/201
2
Ongoing: NO
End Date:
UNK/UNK/
2012Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-14-2020 09:59:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 09:59:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Hernia RepairInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-14-2020 09:59:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
UNK/UNK/2012Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944690
Page 113 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-14-2020 09:59:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
1.b
Date Location User Value Reason
Aug-14-2020 10:00:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Left Foot Toe S
urgery
Start Date: UNK/UNK/200
0
Ongoing: NO
End Date:
UNK/UNK/2
000Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944691
Page 114 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b Line/MH Number:
Date Location User Value Reason
Aug-14-2020 10:00:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 10:00:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Left Foot Toe SurgeryInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-14-2020 10:00:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-14-2020 10:00:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
1.c
Date Location User Value Reason
Aug-14-2020 10:32:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Hypothyroidi
sm
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944692
Page 115 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.c Line/MH Number:
Date Location User Value Reason
Aug-14-2020 10:32:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 10:32:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
HypothyroidismInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-14-2020 10:32:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-14-2020 10:32:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-14-2020 10:33:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Testicular Canc
er
Start Date: Feb/UNK/1998
Ongoing: NO
End Date:
Aug/UNK/1
998Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944693
Page 116 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.d Line/MH Number:
Date Location User Value Reason
Aug-14-2020 10:33:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 10:33:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Testicular CancerInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-14-2020 10:33:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Feb/UNK/1998Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-14-2020 10:33:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NO
End Date:
Aug/UNK/1998Initial Entry
1.e
Date Location User Value Reason
Aug-14-2020 10:33:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:Orchiectomy
Start Date: Mar/UNK/199
8Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944694
Page 117 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Ongoing: NO
End Date:
Mar/UNK/1
998
1.e Line/MH Number:
Date Location User Value Reason
Aug-14-2020 10:33:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 10:33:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
OrchiectomyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-14-2020 10:33:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Mar/UNK/1998Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-14-2020 10:33:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NO
End Date:
Mar/UNK/1998Initial Entry
1.f
Date Location User Value Reason
Aug-14-2020 11:56:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Line/MH Numb
er:6Transcription Error
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944695
Page 118 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Medical History
Term:Chemotherap
y
Start Date: Apr/UNK/199
8
Ongoing: NO
End Date:
Apr/UNK/
1998
Aug-14-2020 10:34:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical Hi
story Term:Chemotherapy for
Testicular Cancer
Start Date: Apr/UNK/1998
Ongoing: NO
End Date:
Apr/UNK/1998Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944696
Page 119 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.f Line/MH Number:
Date Location User Value Reason
Aug-14-2020 10:34:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020
13:01:04
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Cl
osedDiscrepancy has
been closed.
Aug-14-2020
11:56:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: A
nsweredTranscription Error
Aug-14-2020
11:56:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry
:
Chemother
apyTranscription Error
Aug-14-2020
11:49:54
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: O
penedMultiple concepts in
the term
CHEMOTHERAPY
FOR TESTICULAR
CANCER. Split the
term into
CHEMOTHERAPY
and TESTICULAR
CANCER. Submit
each term as a
separate record.
Thank you.
Aug-14-2020
10:34:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry
:
Chemother
apy for Test
icular CancInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944697
Page 120 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
er
1.f Start Date:
Date Location User Value Reason
Aug-14-2020 10:34:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Apr/UNK/1998Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-14-2020 10:34:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NO
End Date:
Apr/UNK/1998Initial Entry
1.g
Date Location User Value Reason
Aug-14-2020 11:28:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:Meniscus Tear
Start Date: UNK/UNK/201
8
Ongoing: NO
End Date:
UNK/UNK/
2018Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944698
Page 121 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.g Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:28:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 11:28:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Meniscus TearInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-14-2020 11:28:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
UNK/UNK/2018Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-14-2020 11:28:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.h
Date Location User Value Reason
Aug-14-2020 11:29:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8
Medical History
Term:Laparoscopic Su
rgery
Start Date: UNK/UNK/201
8Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944699
Page 122 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Ongoing: NO
End Date:
UNK/UNK/2
018
1.h Line/MH Number:
Date Location User Value Reason
Aug-14-2020 11:29:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 11:29:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Laparoscopic SurgeryInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-14-2020 11:29:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
UNK/UNK/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-14-2020 11:29:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.i
Date Location User Value Reason
Aug-17-2020 09:18:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Line/MH Nu
mber:9Transcription Error
(DELETED)
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944700
Page 123 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Medical Hist
ory Term:Modified Krumpli
t Dissection
Start Date: Aug/UNK/1998
Ongoing: NO
End Date:
Aug/UNK/199
8
Aug-14-2020 11:29:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9
Medical Hist
ory Term:Modified Krumpli
t Dissection
Start Date: Aug/UNK/1998
Ongoing: NO
End Date:
Aug/UNK/199
8Initial Entry
1.i Line/MH Number:
Date Location User Value Reason
Aug-17-2020 09:18:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
9Transcription Error
(DELETED)
Aug-14-2020 11:29:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 08:47:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944701
Page 124 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020
09:18:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry
:
Modified Kr
umplit Diss
ectionTranscription Error
(DELETED)
Aug-17-2020
09:18:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: An
sweredTranscription Error
Aug-15-2020
00:27:57
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Op
enedClarify
MODIFIED
KRUMPLIT
DISSECTION as
follows...Clarify
KRUMPLIT. Are
you reporting
MODIFIED
RADICAL NECK
DISSECTION?
MODIFIED
RADICAL
MASTECTOMY?
Other? If so,
update the
verbatim term as
such. Otherwise
clarify and update
the term as
appropriate. Thank
you.
Aug-14-2020
11:29:52
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry
:
Modified Kr
umplit Diss
ectionInitial Entry
1.i Start Date:
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944702
Page 125 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-17-2020 09:18:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Aug/UNK/1998Transcription Error
(DELETED)
Aug-14-2020 11:29:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Aug/UNK/1998Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-17-2020 09:18:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NO
End Date:
Aug/UNK/1998Transcription Error
(DELETED)
Aug-14-2020 11:29:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NO
End Date:
Aug/UNK/1998Initial Entry
1.j
Date Location User Value Reason
Sep-18-2020 10:22:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:10
Medical History T
erm:Seasonal Aller
gies
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944703
Page 126 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.j Line/MH Number:
Date Location User Value Reason
Sep-18-2020 10:22:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 10:22:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Seasonal AllergiesInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-18-2020 10:22:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
UNK/UNK/2015Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-18-2020 10:22:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YESInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944704
Page 127 of 211
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Aug-17-2020 01:22:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed As per site
confirmation
Aug-14-2020 10:10:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Query 1: Answered Original value is
correct
Aug-14-2020 10:05:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Vital signs Date
14/Aug/2020 is not
same as Date of
Visit 13/Aug/2020.
Please review and
update as
appropriate or
clarify.
Aug-14-2020 10:05:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Aug/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-14-2020 10:05:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
220.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-14-2020 10:05:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-14-2020 10:05:49 ACV0PFEINFP6000  Mueed Bari Data Entry: Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944705
Page 128 of 211
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00) Central
Time (US & Canada)72.0
5. Unit:
Date Location User Value Reason
Aug-14-2020 10:05:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-14-2020 10:05:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29.8Initial Entry
7.a
Date Location User Value Reason
Aug-14-2020 10:05:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Record Identifier:: 1
Temperature: 97.8
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-14-2020 10:05:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-14-2020 10:05:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
97.8Initial Entry
7.a Unit:
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944706
Page 129 of 211
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-14-2020 10:05:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-14-2020 10:05:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
FOREHEADInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944707
Page 130 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-14-2020 10:06:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Aug/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-14-2020 10:06:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
50045Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944708
Page 131 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020 10:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 10:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020 10:07:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-14-2020 10:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-14-2020 10:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020 10:07:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BP0YSXInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944709
Page 132 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Aug-14-2020 10:07:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BP0YSXInitial Entry
5.b
Date Location User Value Reason
Aug-14-2020 10:07:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BP0YSYInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-14-2020 10:07:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BP0YSYInitial Entry
5.c
Date Location User Value Reason
Aug-14-2020 10:07:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BP0YSZInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-14-2020 10:07:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BP0YSZInitial Entry
5.d
Date Location User Value Reason
Aug-14-2020 10:07:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BPHHBPInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944710
Page 133 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.d Sample ID
Date Location User Value Reason
Aug-14-2020 10:07:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BPHHBPInitial Entry
5.e
Date Location User Value Reason
Aug-14-2020 10:07:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BPHHBRInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-14-2020 10:07:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BPHHBRInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944711
Page 134 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020 10:07:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 10:07:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020 10:08:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-14-2020 10:07:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-14-2020 10:07:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020 10:08:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BP0Z3BInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944712
Page 135 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Aug-14-2020 10:08:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BP0Z3BInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944713
Page 136 of 211
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-14-2020 10:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-14-2020 10:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-14-2020 10:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-14-2020 10:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Aug/14/2020 09:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-14-2020 10:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-14-2020 10:11:16
(UTC-06:00) CentralACV0PFEINFP6000  Mueed Bari Data Entry:
LEFTInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944714
Page 137 of 211
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-14-2020 10:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-14-2020 10:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-14-2020 10:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YESInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944715
Page 138 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-14-2020 10:11:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944716
Page 139 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020 08:46:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sep/2/2020Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944717
Page 140 of 211
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIGInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0944718
Page 141 of 211
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
UE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944719
Page 142 of 211
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.c Symptom:
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0944720
Page 143 of 211
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944721
Page 144 of 211
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.f Symptom:
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0944722
Page 145 of 211
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.h
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944723
Page 146 of 211
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day the
Subject Diary was complet
ed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944724
Page 147 of 211
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-02-2020 09:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0944725
Page 148 of 211
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020 09:57:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2.a
Date Location User Value Reason
Sep-02-2020 09:57:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.5
Temperature Unit: F
Temperature Locati
on::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-02-2020 09:57:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-02-2020 09:57:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-02-2020 09:57:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0944726
Page 149 of 211
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-02-2020 09:57:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944727
Page 150 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 10:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 10:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 10:30:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 10:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-02-2020 10:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020 10:30:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP0Z8XInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944728
Page 151 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 10:30:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP0Z8XInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944729
Page 152 of 211
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-02-2020 09:58:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020 09:58:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020 09:58:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-02-2020 09:58:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020 09:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020 09:58:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-02-2020 09:58:14
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944730
Page 153 of 211
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-02-2020 09:58:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-02-2020 09:58:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-02-2020 09:58:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944731
Page 154 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020 08:23:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sep/30/2020Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944732
Page 155 of 211
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIGInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0944733
Page 156 of 211
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
UE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944734
Page 157 of 211
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.c Symptom:
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0944735
Page 158 of 211
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944736
Page 159 of 211
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.f Symptom:
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0944737
Page 160 of 211
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.h
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944738
Page 161 of 211
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day the
Subject Diary was complet
ed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944739
Page 162 of 211
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  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
Sep-30-2020 09:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0944740
Page 163 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020 10:23:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020 10:23:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-30-2020 10:23:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-30-2020 10:23:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-30-2020 10:23:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Sep-30-2020 10:23:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9H1KInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944741
Page 164 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Sep-30-2020 10:23:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9H1KInitial Entry
5.b
Date Location User Value Reason
Sep-30-2020 10:23:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9H1LInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-30-2020 10:23:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9H1LInitial Entry
5.c
Date Location User Value Reason
Sep-30-2020 10:23:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9H1MInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-30-2020 10:23:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9H1MInitial Entry
5.d
Date Location User Value Reason
Sep-30-2020 10:23:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTT90Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944742
Page 165 of 211
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.d Sample ID
Date Location User Value Reason
Sep-30-2020 10:23:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTT90Initial Entry
5.e
Date Location User Value Reason
Sep-30-2020 10:23:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTT91Initial Entry
5.e Sample ID
Date Location User Value Reason
Sep-30-2020 10:23:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTT91Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944743
Page 166 of 211
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-02-2020 10:33:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-02-2020 10:33:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-02-2020 10:33:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0944744
Page 167 of 211
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Feb-12-2021 14:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944745
Page 168 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Feb-12-2021 14:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944746
Page 169 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Feb-12-2021 14:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-12-2021 14:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-12-2021 16:59:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-12-2021 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Mar-12-2021 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Urticaria on forehead, posterior
neck, bilateral posterior hands an
d bilateral plantar areasChanged
Information
Mar-10-2021 08:21:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened clinical: pls update
AE term to indicate
if generalized or
specify anatomic
location.
Feb-12-2021 14:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HivesInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944747
Page 170 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-12-2021 14:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-09-2021 14:25:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-08-2021 15:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Mar-08-2021 15:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/16/2021 UNK:UNKNew Information
Mar-03-2021 16:21:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
verify if Hives are
ongoing, then
update the END
DATE and
OUTCOME as
appropriate
Feb-12-2021 14:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-12-2021 14:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
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
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944748
Page 171 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-12-2021 14:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Feb-12-2021 14:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-12-2021 14:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-10-2021 12:43:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-10-2021 09:45:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Mar-10-2021 09:34:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: "Latest action
taken with study
treatment" on AE
form is DRUG
WITHDRAWN and
EOT status in
END_OF_TRT visit
is not ADVERSE
EVENT. Please
consider to update
the EOT2 form
accordingly. Else
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944749
Page 172 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
clarify. Thank you.
Mar-09-2021 16:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNUpdated Per source.
Feb-12-2021 14:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-12-2021 14:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-12-2021 14:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-08-2021 15:34:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-08-2021 15:34:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDChanged Information
Mar-08-2021 15:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Hives:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Feb-12-2021 14:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944750
Page 173 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-12-2021 14:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944751
Page 174 of 211
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Feb-12-2021 14:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-12-2021 14:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-09-2021 18:11:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened clinical: Thanks,
was diagnosis
confirmed by
physician or was
this by self report?
Mar-09-2021 16:06:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Per source, not in
Medical History for
this subject. Per
Investigator, Action
taken to Study
Treatment updated
to Drug Withdrawn.
Feb-19-2021 14:39:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Feb-18-2021 16:13:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened clinical: pls confirm
subject has no prior
hx of angioedema.
Thanks
Feb-18-2021 16:10:55
(UTC-06:00) CentralACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Changed
Information
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944752
Page 175 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
Feb-18-2021 16:10:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Feb-18-2021 16:10:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Angioedema - ForeheadChanged
Information
Feb-18-2021 14:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened clinical: please
confirm subject has
no prior history of
angioedema.
Thanks
Feb-15-2021 13:48:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
provide the
location/ anatomic
site of angioedema
in the answer.
Feb-12-2021 14:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AngioedemaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-12-2021 14:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/11/2021 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-18-2021 16:12:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/16/2021 UNK:UNKNew Information
Feb-17-2021 09:39:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-16-2021 15:25:05 ACV0PFEINFP6000  Query 1: Answered Original value is
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944753
Page 176 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00) Central
Time (US & Canada)correct
Feb-16-2021 08:55:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened clinical: pls confirm
AE still ongoing or
update end date in
CRF. Thanks
Feb-12-2021 14:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-12-2021 14:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
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).
Date Location User Value Reason
Feb-12-2021 14:33:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Feb-12-2021 14:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-12-2021 14:32:57 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944754
Page 177 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00) Central
Time (US & Canada)RELATED
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-09-2021 16:08:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNUpdated Per
source.
Feb-12-2021 14:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-19-2021 14:40:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Feb-18-2021 16:11:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Feb-18-2021 16:11:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESChanged
Information
Feb-17-2021 21:28:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Reissued:Opened GPDClin: Thank
you! Per your
previous answer,
please change to
"Yes" here.
Feb-17-2021 17:15:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject took
Benadryl 50mg
orally and applied
topical
hydrocortisone
cream 2.5% before
contacting site and
reported symptoms
were improving.
Subject was advised
to seek medical
attention if
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944755
Page 178 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
symptoms worsen.
Feb-15-2021 13:49:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
clarify if any
treatment was given.
Feb-12-2021 14:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-12-2021 14:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-18-2021 16:13:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-18-2021 16:13:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDChanged Information
Feb-18-2021 16:12:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Angioedema -
Forehead: Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Feb-12-2021 14:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-12-2021 14:32:57
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944756
Page 179 of 211
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944757
Page 180 of 211
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-08-2021 10:48:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944758
Page 181 of 211
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-08-2021 10:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national reco
mmendations and confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944759
Page 182 of 211
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-08-2021 10:48:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-08-2021 10:48:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944760
Page 183 of 211
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-12-2021 14:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944761
Page 184 of 211
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-12-2021 14:34:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/9/2021Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944762
Page 185 of 211
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-12-2021 14:34:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-12-2021 14:34:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-12-2021 14:34:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944763
Page 186 of 211
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-12-2021 14:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-12-2021 14:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-12-2021 14:35:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-12-2021 14:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-12-2021 14:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/9/2021Initial Entry
5.a
Date Location User Value Reason
Feb-12-2021 14:35:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR2Z94Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944764
Page 187 of 211
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User ValueReason
Feb-19-2021
15:31:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Feb-19-2021
10:19:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredChanged data per
query
Feb-18-2021
09:07:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM: Please update
data per query
response provided.
Thank you.
Feb-17-2021
08:32:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Candi
dateDM: Please update
data per query
response provided.
Thank you.
Feb-16-2021
15:19:29
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredPlease unlock all
forms in
V101_VAX3 for
11711161 so changes
may be made
Feb-16-2021
05:30:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW7250542;The
barcode BR2Z94 is
recorded for two
subjects 11711023,
and 11711161, please
review and update as
appropriate.
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944765
Page 188 of 211
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-12-2021
14:35:02
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BR2Z
94Initial Entry
5.b
Date Location User Value Reason
Feb-12-2021 14:35:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR2Z95Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944766
Page 189 of 211
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.b Sample ID
Date Location User ValueReason
Feb-19-2021
15:31:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Feb-19-2021
10:19:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredChanged data per
query
Feb-19-2021
04:19:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM1: The requested
page is unfrozen.
Please have the
changes done to
remove the duplicate
barcode BR2Z95 .
Feb-17-2021
09:59:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Candi
datePending 11711161
update
Feb-16-2021
15:19:08
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredPlease unlock all
forms in
V101_VAX3 for
11711161 so changes
may be made
Feb-16-2021
05:30:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW7250543;The
barcode BR2Z95 is
recorded for two
subjects 11711023,
and 11711161, please
review and update as
appropriate.
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944767
Page 190 of 211
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-12-2021
14:35:09
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BR2Z
95Initial Entry
5.c
Date Location User Value Reason
Feb-12-2021 14:35:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR2Z96Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944768
Page 191 of 211
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User ValueReason
Feb-19-2021
15:31:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Feb-19-2021
10:19:53
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredChanged data per
query
Feb-18-2021
09:08:00
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM: Please update
data per query
response provided.
Thank you.
Feb-17-2021
08:32:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Candi
dateDM: Please update
data per query
response provided.
Thank you.
Feb-16-2021
15:18:10
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredPlease unlock all
forms in v101_VAX3
for subject 11711161
so changes may be
made
Feb-16-2021
05:30:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW7250544;The
barcode BR2Z96 is
recorded for two
subjects 11711023,
and 11711161, please
review and update as
appropriate.
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944769
Page 192 of 211
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-12-2021
14:35:15
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BR2Z
96Initial Entry
5.d
Date Location User Value Reason
Feb-12-2021 14:35:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLG59LInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944770
Page 193 of 211
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.d Sample ID
Date Location User ValueReason
Feb-19-2021
15:31:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Feb-19-2021
10:21:28
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dChanged data per
query
Feb-17-2021
00:00:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM : For subject
11711161 :
ELECTRONIC
SAMPLE
TRACKING -
IMMUNOGENICITY
in V101XAX3 is
unfrozen now. Please
review and update the
data per previous
query. Thank you.
Feb-16-2021
15:18:59
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dPlease unlock all
forms in V101_VAX3
for 11711161 so
changes may be made
Feb-16-2021
05:30:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7250540;The
barcode BLG59L is
recorded for two
subjects 11711023,
and 11711161, please
review and update as
appropriate.
Feb-12-2021
14:35:21ACV0PFEINFP6000  Data
EntryInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944771
Page 194 of 211
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00)
Central Time
(US &
Canada):
BLG5
9L
5.e
Date Location User Value Reason
Feb-12-2021 14:35:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLG59MInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944772
Page 195 of 211
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.e Sample ID
Date Location User ValueReason
Feb-19-2021
15:31:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Feb-19-2021
10:21:39
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredChanged data per
query
Feb-17-2021
08:31:23
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM: Please update
data per query
response provided.
Thank you.
Feb-16-2021
15:18:52
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredPlease unlock all
forms in
V101_VAX3 for
11711161 so changes
may be made
Feb-16-2021
05:30:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW7250541;The
barcode BLG59M is
recorded for two
subjects 11711023,
and 11711161, please
review and update as
appropriate.
Feb-12-2021
14:35:27
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BLG5
9MInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944773
Page 196 of 211
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-12-2021 14:35:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-12-2021 14:35:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-12-2021 14:35:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-12-2021 14:35:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-12-2021 14:35:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/9/2021Initial Entry
5.a
Date Location User Value Reason
Feb-12-2021 14:35:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR2Z93Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944774
Page 197 of 211
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User ValueReason
Feb-19-2021
15:31:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Feb-19-2021
10:21:52
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredChanged data per
query
Feb-19-2021
04:19:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM1: The requested
page is unfrozen.
Please have the
changes done to
remove the duplicate
barcode BR2Z93.
Feb-17-2021
09:59:02
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Candi
datePending 11711161
update
Feb-16-2021
15:19:15
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredPlease unlock all
forms in
V101_VAX3 for
11711161 so changes
may be made
Feb-16-2021
05:30:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW7250545;The
barcode BR2Z93 is
recorded for two
subjects 11711023,
and 11711161, please
review and update as
appropriate.
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944775
Page 198 of 211
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-12-2021
14:35:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BR2Z
93Initial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944776
Page 199 of 211
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-12-2021 14:36:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-12-2021 14:36:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-12-2021 14:36:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-12-2021 14:36:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021 11:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-12-2021 14:36:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-12-2021 14:36:59
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944777
Page 200 of 211
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7. Route:
Date Location User Value Reason
Feb-12-2021 14:36:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-12-2021 14:36:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-12-2021 14:36:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-12-2021 14:36:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-12-2021 14:36:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944778
Page 201 of 211
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021 00:08:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Saumitra
DubeyQuery 1: Closed Response satisfies
query
Mar-11-2021 12:31:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Mar-11-2021 05:44:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM1: Thank you
for reply. However,
Form level
comment is still
missing on VACIN
TRT form. Kindly
erase all item level
comments and then
add form level
comment by
selecting Not Done
or Not Applicable
radio button option
on VACIN TRT
form or else clarify.
Mar-10-2021 09:54:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Mar-10-2021 00:15:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: DOV marked
as Not Done.
However, form
level comment is
not present on rest
of forms. Kindly
erase all the data
and item level
comments on rest
of forms and then
add form level
comment by
selecting Not Done
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944779
Page 202 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
or Not Applicable
option on rest of
forms.
Mar-09-2021 16:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-10-2021 09:54:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944780
Page 203 of 211
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-10-2021 09:54:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not DoneInitial Entry
Mar-10-2021 09:53:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Mar-09-2021 16:15:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-10-2021 09:54:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not DoneInitial Entry
Mar-10-2021 09:53:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Mar-09-2021 16:15:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-10-2021 09:54:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Mar-10-2021 09:53:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-10-2021 09:53:53
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae3d4a\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944781
Page 204 of 211
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Tr
…[truncated]