Document text
Page 1 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976746
Page 2 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/4/2020
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976747
Page 3 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [11091164]
2.Birth Date: /1961
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976748
Page 4 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/4/2020
2.Erroneous Visit
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976749
Page 5 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976750
Page 6 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976751
Page 7 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: Jan/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Postmenopausal]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOARTHRITIS BILATERAL KNEES]
Start Date: UNK/UNK/2000
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976752
Page 8 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Total Knee Replacement ]
Start Date: Aug/31/2020
Ongoing: NO
End Date:
Aug/31/2020
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976753
Page 9 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Aug/4/2020
2.Weight: [246.0]
3.Unit: LB
4.Height: [61.0]
5.Unit: in
6.Body Mass Index: [46.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976754
Page 10 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/4/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976755
Page 11 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/4/2020
2.Randomization Number: [222439]
3.Randomization Group: [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976756
Page 12 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/4/2020
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 [BP3R45]
5.bSample ID [BP3R46]
5.cSample ID [BP3R47]
5.dSample ID [BPL6BZ]
5.eSample ID [BPL6C0]
5.fSample ID [BPL6C1]
5.gSample ID [BPL6C2]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976757
Page 13 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/4/2020
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 [BPXZDY]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976758
Page 14 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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/4/2020 15:51
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
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976759
Page 15 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976760
Page 16 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976761
Page 17 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976762
Page 18 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976763
Page 19 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976764
Page 20 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/24/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976765
Page 21 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BPXSCD]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976766
Page 22 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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/24/2020 11:32
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
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976767
Page 23 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976768
Page 24 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976769
Page 25 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976770
Page 26 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/21/2020
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 [BPXV2G]
5.bSample ID [BMNG0S]
5.cSample ID [BMNG0T]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976771
Page 27 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976772
Page 28 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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: [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976773
Page 29 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976774
Page 30 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976775
Page 31 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976776
Page 32 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976777
Page 33 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976778
Page 34 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976779
Page 35 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976780
Page 36 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Unplanned Assessments
1.Assessments
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976781
Page 37 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Sep/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976782
Page 38 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976783
Page 39 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976784
Page 40 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976785
Page 41 of 195
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instance
1.ADVERSE EV
ENT 1 Deep Vein Throm
bosis Sep/7/2020 UNK:
UNK YES Repeating
Pages
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976786
Page 42 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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)[Deep Vein Thrombosis]
4.Start Date Time: Sep/7/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 4
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).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Right Total Knee Replacement on 31 Aug 2020]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976787
Page 43 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020365523]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976788
Page 44 of 195
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976789
Page 45 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976790
Page 46 of 195
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976791
Page 47 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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: //
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976792
Page 48 of 195
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976793
Page 49 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976794
Page 50 of 195
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976795
Page 51 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976796
Page 52 of 195
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976797
Page 53 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976798
Page 54 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976799
Page 55 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976800
Page 56 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976801
Page 57 of 195
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976802
Page 58 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976803
Page 59 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976804
Page 60 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976805
Page 61 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976806
Page 62 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/2/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976807
Page 63 of 195
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976808
Page 64 of 195
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976809
Page 65 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/15/2021
2.Erroneous Visit
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976810
Page 66 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/15/2021
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976811
Page 67 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976812
Page 68 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death :Feb/15/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976813
Page 69 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976814
Page 70 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/15/2021
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 [BRGKLC]
5.bSample ID [BS37N8]
5.cSample ID [BS37N9]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976815
Page 71 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/15/2021
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 [BRGKL2]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976816
Page 72 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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/15/2021 14:39
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
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976817
Page 73 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976818
Page 74 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/8/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976819
Page 75 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/8/2021
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 [BRF6BW]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976820
Page 76 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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: Mar/8/2021 14:14
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
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976821
Page 77 of 195
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976822
Page 78 of 195
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976823
Page 79 of 195
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976824
Page 80 of 195
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976825
Page 81 of 195
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976826
Page 82 of 195
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976827
Page 83 of 195
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976828
Page 84 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/21/2020
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976829
Page 85 of 195
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976830
Page 86 of 195
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Bruce Rankin Approved Mar-09-2021 13:30:54 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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.
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976831
Page 87 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormAug-04-2020 16:44:40 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0976832
Page 88 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-16-2021 06:07:29 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0976833
Page 89 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-16-2021 06:08:26 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0976834
Page 90 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Feb-16-2021 06:08:26 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0976835
Page 91 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Feb-16-2021 06:08:26 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0976836
Page 92 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Feb-16-2021 06:08:26 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0976837
Page 93 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Feb-16-2021 06:08:26 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0976838
Page 94 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Feb-16-2021 06:08:26 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0976839
Page 95 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aFeb-16-2021 06:08:26 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0976840
Page 96 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aFeb-16-2021 06:08:26 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0976841
Page 97 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aFeb-16-2021 06:08:26 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0976842
Page 98 of 195
***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, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Bruce Rankin Approved Mar-09-2021 13:30:54 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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-16-2021 06:05:52 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin Approved Oct-12-2020 10:04:05 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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 Oct-12-2020 09:31:34 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976843
Page 99 of 195
***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, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Bruce Rankin Approved Oct-12-2020 08:50:54 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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 Oct-09-2020 07:07:59 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin Approved Oct-08-2020 13:05:11 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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 Sep-21-2020 15:03:52 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin Approved Sep-11-2020 17:41:17 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976844
Page 100 of 195
***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, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Affidavit:
By my dated signature below, I, BruceRankin, 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.
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976845
Page 101 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-04-2020 16:44:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-04-2020 16:44:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976846
Page 102 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-04-2020 16:44:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/4/2020Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976847
Page 103 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-04-2020 16:43:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11091164Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-04-2020 16:43:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1961Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-04-2020 16:44:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-04-2020 16:44:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 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-04-2020 16:44:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976848
Page 104 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-04-2020 16:44:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976849
Page 105 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-04-2020 16:44:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-04-2020 16:44:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-04-2020 16:44:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976850
Page 106 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.a
Date Location User Value Reason
Aug-04-2020 16:46:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:Anxiety
Start Date: Jan/UNK/20
10
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-04-2020 16:46:09
(UTC-05:00) Eastern
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-04-2020 16:46:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AnxietyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-04-2020 16:46:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-04-2020 16:46:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976851
Page 107 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-05-2020 11:32:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Postmenopa
usal
Start Date: UNK/UNK/
2017
Ongoing: YESInitial Entry
Aug-04-2020 16:48:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Postmenopa
usal
Start Date:
Ongoing: YESInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976852
Page 108 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.b Line/MH Number:
Date Location User Value Reason
Aug-04-2020 16:48:00
(UTC-05:00) Eastern
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-04-2020 16:48:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PostmenopausalInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-05-2020 11:32:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-04-2020 16:48:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-23-2020 12:04:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:3
Medical Hi
story Term
:OSTEOARTHRITI
S BILATERAL KN
EES
Start Date: UNK/UNK/2000
Ongoing: YESChanged
Information
Sep-23-2020 12:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0976853
Page 109 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Medical History
Term:OSTEOARTH
RITIS
Start Date: UNK/UNK/20
00
Ongoing: YES
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976854
Page 110 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.c Line/MH Number:
Date Location User Value Reason
Sep-23-2020 12:04:11
(UTC-05:00) Eastern
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
Oct-08-2020 12:17:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-08-2020 11:29:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Updated
Oct-07-2020 12:14:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL please
consider relevance of
OBESITY (BMI
46.5) to current
conditions DVT and
knee
OA/replacement; if
appropriate, update
Med Hx and submit
safety update.
Sep-23-2020 12:04:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OSTEOARTHRITIS BILATER
AL KNEESChanged Information
Sep-23-2020 12:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OSTEOARTHRITISInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-23-2020 12:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (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-2021-5683-0976855
Page 111 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Sep-23-2020 12:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-08-2020 11:29:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History T
erm:Obesity
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0976856
Page 112 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.d Line/MH Number:
Date Location User Value Reason
Oct-08-2020 11:29:35
(UTC-05:00) Eastern
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
Oct-08-2020 11:29:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ObesityInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-08-2020 11:29:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-08-2020 11:29:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-09-2020 07:09:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:Total Knee Repl
acement
Start Date: Aug/31/2020
Ongoing: NO
End Date:
Aug/31/2020Changed
Information
(DELETED)
Oct-08-2020 12:30:51 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0976857
Page 113 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Num
ber:5
Medical Histor
y Term:Total Knee Repl
acement
Start Date: Aug/31/2020
Ongoing: NO
End Date:
Aug/31/2020
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976858
Page 114 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.e Line/MH Number:
Date Location User Value Reason
Oct-09-2020 07:09:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
5Changed
Information
(DELETED)
Oct-08-2020 12:30:51
(UTC-05:00) Eastern
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
Oct-09-2020 07:09:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Total Knee ReplacementChanged
Information
(DELETED)
Oct-08-2020 12:30:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Total Knee ReplacementInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-09-2020
13:33:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedResponse satisfies
query
Oct-09-2020
13:32:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 3:
ClosedResponse satisfies
query
Oct-09-2020
13:31:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
ClosedResponse satisfies
query
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (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)
FDA-CBER-2021-5683-0976859
Page 115 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Oct-09-2020
07:09:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 3:
Answere
dChanged data per
query
Oct-09-2020
07:09:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
Aug/31/
2020Changed
Information
(DELETED)
Oct-09-2020
07:09:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3:
OpenedStart Date is after
or equal to the first
vaccination date
04/Aug/2020.
Please review and
update as
appropriate.
Oct-09-2020
07:09:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2:
Answere
dChanged
Information
Oct-09-2020
07:09:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answere
dAnswer Auto
Query
Oct-09-2020
06:01:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
Reissued
:OpenedDM: If date is
correct, please
consider moving
event to the
Adverse Event
CRF per protocol
instructions.
Oct-08-2020
15:48:38
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2:
OpenedDMW4924943;The
Medical History
condition 'Start
Date' is after the
first study
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0976860
Page 116 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Canada) treatment 'Start
Date'. Please
review. If date is
correct, consider
moving event to the
Adverse Event
CRF per protocol
instructions.
Oct-08-2020
12:33:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
Answere
dSubject had knee
replacement after
vaccination due to
osteoarthritis of the
knee
Oct-08-2020
12:30:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
OpenedStart Date is after
or equal to the first
vaccination date
04/Aug/2020.
Please review and
update as
appropriate.
Oct-08-2020
12:30:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
Aug/31/
2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-09-2020 07:09:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/31/2020Changed
Information
(DELETED)
Oct-08-2020 12:30:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/31/2020Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976861
Page 117 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Aug-04-2020 16:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-04-2020 16:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
246.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-04-2020 16:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-04-2020 16:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
61.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-04-2020 16:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-04-2020 16:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
46.5Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976862
Page 118 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7.a
Date Location User Value Reason
Aug-04-2020 16:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 97.9
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-04-2020 16:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-04-2020 16:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-04-2020 16:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-04-2020 16:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976863
Page 119 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-04-2020 16:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-04-2020 16:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-04-2020 16:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-04-2020 16:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-04-2020 16:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-04-2020 16:47:44
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976864
Page 120 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Aug-04-2020 16:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-04-2020 16:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-04-2020 16:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976865
Page 121 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-04-2020 16:48:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-04-2020 16:48:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
222439Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976866
Page 122 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-04-2020 16:48:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-04-2020 16:48:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-05-2020 13:45:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-05-2020 01:02:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM review:
'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Thank you.
Aug-04-2020 16:48:23
(UTC-05:00) Eastern
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-04-2020 16:48:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/4/2020Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976867
Page 123 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Aug-11-2020 22:18:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-07-2020 14:03:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Aug-06-2020 23:06:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Subject is listed to
have 3 serum
samples taken for
immunogenicity,
which is less than the
5 samples expected.
Please can you
review and update
Q4 if serum was not
taken per protocol,
Else clarify.
5.a
Date Location User Value Reason
Aug-05-2020 13:45:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3R45Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-05-2020 13:45:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3R45Initial Entry
5.b
Date Location User Value Reason
Aug-05-2020 13:45:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3R46Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (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)
FDA-CBER-2021-5683-0976868
Page 124 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.b Sample ID
Date Location User Value Reason
Aug-05-2020 13:45:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3R46Initial Entry
5.c
Date Location User Value Reason
Aug-05-2020 13:46:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3R47Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-05-2020 13:46:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3R47Initial Entry
5.d
Date Location User Value Reason
Aug-07-2020 14:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPL6BZInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-07-2020 14:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPL6BZInitial Entry
5.e
Date Location User Value Reason
Aug-07-2020 14:02:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPL6C0Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (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)
FDA-CBER-2021-5683-0976869
Page 125 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.e Sample ID
Date Location User Value Reason
Aug-07-2020 14:02:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPL6C0Initial Entry
5.f
Date Location User Value Reason
Aug-07-2020 14:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPL6C1Initial Entry
5.f Sample ID
Date Location User Value Reason
Aug-07-2020 14:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPL6C1Initial Entry
5.g
Date Location User Value Reason
Aug-07-2020 14:03:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPL6C2Initial Entry
5.g Sample ID
Date Location User Value Reason
Aug-07-2020 14:03:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPL6C2Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976870
Page 126 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-04-2020 16:48:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-04-2020 16:48:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-05-2020 12:48:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-05-2020 01:02:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM review:
'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Thank you.
Aug-04-2020 16:48:29
(UTC-05:00) Eastern
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-04-2020 16:48:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/4/2020Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976871
Page 127 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.a
Date Location User Value Reason
Aug-05-2020 12:48:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXZDYInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-05-2020 12:48:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXZDYInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976872
Page 128 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-04-2020 16:48:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-04-2020 16:48:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-04-2020 16:48:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-04-2020 16:48:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020 15:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-04-2020 16:48:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-04-2020 16:48:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976873
Page 129 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7. Route:
Date Location User Value Reason
Aug-04-2020 16:48:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-04-2020 16:48:50
(UTC-05:00) Eastern
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-04-2020 16:48:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976874
Page 130 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-04-2020 16:48:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-D
IARY COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976875
Page 131 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-24-2020 14:48:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0976876
Page 132 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
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
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIGInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (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-2021-5683-0976877
Page 133 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
UE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NO
2.b Symptom:
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
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
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0976878
Page 134 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.c Symptom:
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
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
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
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
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (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-2021-5683-0976879
Page 135 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
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
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0976880
Page 136 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.f Symptom:
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
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
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (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-2021-5683-0976881
Page 137 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.h
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
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 compl
eted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0976882
Page 138 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.a
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
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
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0976883
Page 139 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
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
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
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
Aug-24-2020 14:49:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (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-2021-5683-0976884
Page 140 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Aug-24-2020 14:54:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2.a
Date Location User Value Reason
Aug-24-2020 14:54:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.0
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-24-2020 14:54:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-24-2020 14:54:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.0Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-24-2020 14:54:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (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-2021-5683-0976885
Page 141 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-24-2020 14:54:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0976886
Page 142 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-24-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-24-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-24-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-24-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-24-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-24-2020 14:55:07
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0976887
Page 143 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-24-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-24-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-24-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0976888
Page 144 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020 14:55:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020 14:55:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020 16:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-24-2020 14:55:15
(UTC-05:00) Eastern
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-24-2020 14:55:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-24-2020 16:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXSCDInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0976889
Page 145 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.a Sample ID
Date Location User Value Reason
Aug-24-2020 16:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXSCDInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976890
Page 146 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-24-2020 14:55:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-24-2020 14:55:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-24-2020 14:55:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-24-2020 14:55:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020 11:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-24-2020 14:55:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-24-2020 14:55:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0976891
Page 147 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7. Route:
Date Location User Value Reason
Aug-24-2020 14:55:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-24-2020 14:55:36
(UTC-05:00) Eastern
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-24-2020 14:55:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0976892
Page 148 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-21-2020 15:23:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976893
Page 149 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
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 co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
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-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIGInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976894
Page 150 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
UE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
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-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976895
Page 151 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.c Symptom:
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
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-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
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-21-2020 15:24:06
(UTC-05:00) Eastern
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-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976896
Page 152 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
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-21-2020 15:24:06
(UTC-05:00) Eastern
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-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
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
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976897
Page 153 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.f Symptom:
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
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-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
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-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976898
Page 154 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.h
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
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-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976899
Page 155 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.a
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day th
e Subject Diary was compl
eted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
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-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
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
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976900
Page 156 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
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-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the las
t day the Subject Diary
was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-21-2020 15:24:06
(UTC-05:00) Eastern
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-21-2020 15:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976901
Page 157 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 15:24:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 15:24:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020 06:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-22-2020 03:41:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-21-2020 15:24:20
(UTC-05:00) Eastern
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-21-2020 15:24:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
5.a
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976902
Page 158 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Sep-22-2020 06:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXV2GInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020 06:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXV2GInitial Entry
5.b
Date Location User Value Reason
Sep-22-2020 07:14:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMNG0SInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-22-2020 07:14:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMNG0SInitial Entry
5.c
Date Location User Value Reason
Sep-22-2020 07:14:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMNG0TInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-22-2020 07:14:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMNG0TInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (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)
FDA-CBER-2021-5683-0976903
Page 159 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-22-2020 13:28:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-22-2020 13:28:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-22-2020 13:28:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0976904
Page 160 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Sep-21-2020 15:03:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976905
Page 161 of 195
***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, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Oct-04-2020 21:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed wrong location
Oct-04-2020 21:06:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed wrong location
Sep-29-2020 07:53:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINQUERY -
please consider
relevance of
OBESITY (BMI
46.5) to current
medical illness; if
appropriate, update
Med Hx and submit
safety update.
Sep-29-2020 07:51:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY - Per
SAE report, date of
Injection #2 was 22
Aug 2020; however,
this does not match
with CRF. Please
evaluate, and update
in the appropriate
location.
Sep-21-2020 15:03:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-21-2020 15:03:52
(UTC-05:00) Eastern
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
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976906
Page 162 of 195
***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, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Oct-29-2020 16:06:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Oct-29-2020 14:03:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Oct-29-2020 08:53:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered Follow-up SAE was
submitted
28Oct2020
Oct-28-2020 23:50:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Reissued:Opened Clinical – Thank
you. Please submit a
follow-up SAE
form, stating no
COVID test was
performed in Hosp,
as pertinent
information for this
trial.
Oct-28-2020 12:04:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered SARS-CoV-2 test
was not done while
in the hospital. SAE
follow-up sent.
Oct-28-2020 12:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered SARS-CoV-2 test
was not done while
in the hospital.
Oct-27-2020 23:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened Clinical – If NO
hospital Covid test
was performed is
known, please
submit this
information on a
follow-up SAE
form, as pertinent
information for this
trial.
Oct-27-2020 10:27:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 3: Reissued:Opened Clin: Please provide
SARS-CoV-2 tests
results and update
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (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) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0976907
Page 163 of 195
***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, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
accordingly the
initial SAE report
(AER# 2020365523)
via an SAE
follow-up report.
Oct-19-2020 07:16:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered No SARS-CoV-2
tests were preformed
Oct-18-2020 16:12:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 3: Opened Clin: Please confirm
if any SARS-CoV-2
(NAAT or other)
tests were
performed. Please
provide any test
results and update
accordingly the
initial SAE report
via an SAE
follow-up report.
Oct-12-2020 10:11:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Oct-09-2020 15:58:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Updated and sent
Oct-08-2020 12:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened CLINICAL please
send a SAE safety
update to correct the
Inj #2 date
Oct-08-2020 11:26:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Subject was
vaccinated on
24Aug2020, inform
is correct
Oct-07-2020 12:13:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed move to med Hx
CRF
Oct-04-2020 21:06:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINQUERY - Per
SAE report, date of
Injection #2 was 22
Aug 2020; however,
this does not match
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (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) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0976908
Page 164 of 195
***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, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
with CRF. Please
evaluate, and update
in the appropriate
location.
Oct-04-2020 21:06:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY -
please consider
relevance of
OBESITY (BMI
46.5) to current
medical illness; if
appropriate, update
Med Hx and submit
safety update.
Sep-21-2020 15:03:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Deep Vein ThrombosisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-21-2020 15:03:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-21-2020 15:03:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-21-2020 15:03:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial 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
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976909
Page 165 of 195
***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, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
Sep-22-2020 04:52:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-22-2020 01:11:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened For AE Deep Vein
Thrombosis :
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Sep-21-2020 15:03:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Deep Vein
Thrombosis :
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Sep-21-2020 15:03:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabili
ty/incapacity?Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976910
Page 166 of 195
***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, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
NO
Is this serious event life threate
ning?
NO
Other medically important serio
us event
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.
Date Location User Value Reason
Sep-21-2020 15:03:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-12-2020 10:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies query
Oct-12-2020 09:31:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Changed Information
Oct-12-2020 09:31:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is due
to:
OTHER
If Other, specify:
Right Total Knee Rep
lacement on 31 Aug 2
020Changed Information
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976911
Page 167 of 195
***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, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Oct-11-2020 21:31:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Reissued:Opened CLINICAL NO Date
Added - please update
Other reason for DVT to
Total knee replacement
(right) on 31 Aug 2020;
this provides the date prior
to DVT when surgery
occurred
Oct-09-2020 17:06:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Changed Information
Oct-09-2020 17:06:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is due
to:
OTHER
If Other, specify:
Right Total Knee Rep
lacementChanged Information
Oct-09-2020 17:04:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Reissued:Opened CLINICAL please update
Other reason for DVT to
Total knee replacement
(right) on 31 Aug 2020;
this provides the date prior
to DVT when surgery
occurred
Oct-09-2020 07:07:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Changed Information
Oct-09-2020 07:07:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is due
to:
OTHER
If Other, specify:
Total Knee ReplacemChanged Information
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976912
Page 168 of 195
***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, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
ent
Oct-08-2020 13:59:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Reissued:Opened CLINICAL TKR cannot be
added to past Med history
as it occurred after study
enrollment (delete in Med
Hx CRF); it is a procedure
for knee OA past med Hx.
Please add the procedure
date here, in Other reason
for the SAE.
Oct-08-2020 12:34:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Updated
Sep-29-2020 07:49:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened CLINQE|UERY - please
add TKR date (31 Aug
2020) to relationship
answer, as not previously
part of Med Hx
Sep-23-2020 06:01:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Sep-23-2020 04:44:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Charu
SabharwalQuery 2: Closed clinical_will reissue on
med hx CRF
Sep-22-2020 15:38:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Please unlock medical
history since osteoarthritis
of knee was preexisting
causing the need for total
knee replacement.
Sep-22-2020 14:21:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened ClinQuery Condition
requiring total knee
replacement is not
available in Med history (if
predates study) or as an
AE; please update medical
condition in appropriate
location
Sep-22-2020 13:27:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered A follow-up report for the
SAE for subject 1109-164
was just faxed with the
causality.
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (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) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0976913
Page 169 of 195
***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, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-22-2020 04:54:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020365523
causality was reported NO
DATA in Safety database
while NOT RELATED in
AE CRF. Please confirm. If
safety update is required,
please submit a follow-up
form.
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976914
Page 170 of 195
***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, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-21-2020 15:03:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
Knee replacement surgeryInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-21-2020 15:08:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-21-2020 15:08:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-21-2020 15:08:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-21-2020 15:03:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976915
Page 171 of 195
***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, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-21-2020 15:03:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-22-2020 04:52:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020365523Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976916
Page 172 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-16-2021 06:06:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/3/2021Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976917
Page 173 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-16-2021 06:06:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national reco
mmendations and confirmed to
have received only placebo at
Vaccination 1/2Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976918
Page 174 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date Treatment Unblinded :
Date Location User ValueReason
Mar-03-2021
16:22:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
seddata confirmed
Mar-03-2021
10:40:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dDates are correct as
entered and confirm
unblind occurred prior
to subject confirmation
in error
Mar-02-2021
00:19:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM: Date treatment
unblinded should be
after or same REVAX
date when reason is
ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION.
Please verify and
update dates as
appropriate or else
clarify with the
comment. Thank you.
Mar-01-2021
20:39:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dOriginal value is
correct
Feb-23-2021
01:21:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7351264;Date
Treatment Unblinded
should be equal to or
after DOV in REVAX
CONTACT visit when
Reason is ASSESS
ELIGIBILITY FOR
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0976919
Page 175 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
ADDITIONAL
VACCINATION.Please
review and update as
appropriate.
Feb-16-2021
06:05:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Feb/2/
2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-16-2021 06:05:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976920
Page 176 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-16-2021 06:06:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/15/2021Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976921
Page 177 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-16-2021 06:07:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/15/2021Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976922
Page 178 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-16-2021 06:07:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/15/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-16-2021 06:07:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-16-2021 06:07:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976923
Page 179 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-16-2021 06:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-16-2021 06:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-16-2021 06:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-16-2021 06:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-16-2021 06:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Feb-16-2021 06:08:26
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (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)
FDA-CBER-2021-5683-0976924
Page 180 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada) Sponsor-Defined Id
entifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
able
6.a Sponsor ID:
Date Location User Value Reason
Feb-16-2021 06:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Feb-16-2021 06:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Feb-16-2021 06:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Feb-16-2021 06:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976925
Page 181 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-16-2021 06:08:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-16-2021 06:08:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-17-2021 16:45:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-17-2021 08:09:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-16-2021 06:08:44
(UTC-05:00) Eastern
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-16-2021 06:08:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/15/2021Initial Entry
5.a
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976926
Page 182 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Feb-17-2021 16:45:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRGKLCInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-17-2021 16:45:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRGKLCInitial Entry
5.b
Date Location User Value Reason
Feb-17-2021 16:45:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS37N8Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-17-2021 16:45:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS37N8Initial Entry
5.c
Date Location User Value Reason
Feb-17-2021 16:45:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS37N9Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-17-2021 16:45:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS37N9Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (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)
FDA-CBER-2021-5683-0976927
Page 183 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-16-2021 06:08:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-16-2021 06:08:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-17-2021 16:48:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-17-2021 08:09:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-16-2021 06:08:56
(UTC-05:00) Eastern
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-16-2021 06:08:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/15/2021Initial Entry
5.a
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976928
Page 184 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Feb-17-2021 16:48:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRGKL2Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-17-2021 16:48:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRGKL2Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976929
Page 185 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-16-2021 06:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-16-2021 06:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-16-2021 06:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-16-2021 06:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/15/2021 14:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-16-2021 06:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-16-2021 06:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976930
Page 186 of 195
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7. Route:
Date Location User Value Reason
Feb-16-2021 06:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-16-2021 06:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-16-2021 06:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-16-2021 06:09:54
(UTC-05:00) Eastern
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-16-2021 06:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976931
Page 187 of 195
***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, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021 15:48:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/8/2021Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976932
Page 188 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-08-2021 15:48:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Mar-08-2021 15:48:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Mar-08-2021 15:48:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/8/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Mar-08-2021 15:48:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Mar-08-2021 15:48:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Mar-08-2021 15:48:19
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976933
Page 189 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Mar-08-2021 15:48:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Mar-08-2021 15:48:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Mar-08-2021 15:48:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976934
Page 190 of 195
***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, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021 15:48:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021 15:48:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-09-2021 07:35:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-09-2021 05:51:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-08-2021 15:48:30
(UTC-05:00) Eastern
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.
Mar-08-2021 15:48:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/8/2021Initial Entry
5.a
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976935
Page 191 of 195
***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, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Mar-09-2021 07:35:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRF6BWInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-09-2021 07:35:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRF6BWInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976936
Page 192 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-08-2021 15:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-08-2021 15:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-08-2021 15:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-08-2021 15:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/8/2021 14:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-08-2021 15:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-08-2021 15:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976937
Page 193 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7. Route:
Date Location User Value Reason
Mar-08-2021 15:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-08-2021 15:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-08-2021 15:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-08-2021 15:51:36
(UTC-05:00) Eastern
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
Mar-08-2021 15:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976938
Page 194 of 195
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject Status
Date Location User Value Reason
Sep-22-2020 13:28:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-04-2020 16:48:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-04-2020 16:44:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Sep-22-2020 13:28:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/21/2020Initial Entry
Aug-04-2020 16:48:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/4/2020Initial Entry
Aug-04-2020 16:44:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/4/2020Initial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976939
Page 195 of 195
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-11-2020 16:57:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3ecd\Final\Final On: 01-Apr-2021 05:02 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976940