Document text
Page 1 of 176
***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: 11091036 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
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975626
Page 2 of 176
***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: 11091036 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
Jul/30/2020
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975627
Page 3 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [11091036]
2.Birth Date: /1960
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:
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975628
Page 4 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/30/2020
2.Erroneous Visit
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975629
Page 5 of 176
***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: 11091036 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
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975630
Page 6 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathJul/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975631
Page 7 of 176
***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: 11091036 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:[Acid Reflux]
Start Date: Jan/1/2013
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Asthma]
Start Date: Jan/1/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Bipolar Disorder]
Start Date: Jan/1/1985
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Hypothyroidism]
Start Date: Jan/1/2002
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Major Depressive Disorder]
Start Date: Jan/1/1985
Ongoing: YES
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975632
Page 8 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Jul/30/2020
2.Weight: [162.4]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [27.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975633
Page 9 of 176
***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: 11091036 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: Jul/30/2020
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:
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975634
Page 10 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition
1.Randomization Date : Jul/30/2020
2.Randomization Number: [220717]
3.Randomization Group: [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975635
Page 11 of 176
***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: 11091036 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:
Jul/30/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPLG8Z]
5.bSample ID [BPLG90]
5.cSample ID [BPLG91]
5.dSample ID [BPLG92]
5.eSample ID [BP3R8Z]
5 fSample ID [BP3R90]
5.gSample ID [BP3R91]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975636
Page 12 of 176
***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: 11091036 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:
Jul/30/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3R92]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975637
Page 13 of 176
***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: 11091036 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: Jul/30/2020 16:15
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
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975638
Page 14 of 176
***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: 11091036 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
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975639
Page 15 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/18/2020
2.Erroneous Visit
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975640
Page 16 of 176
***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: 11091036 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
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975641
Page 17 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975642
Page 18 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Aug/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975643
Page 19 of 176
***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: 11091036 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/18/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113] Comments
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE Comments
Not Done: Comments
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975644
Page 20 of 176
***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: 11091036 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/18/2020
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 [BPXRW4]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975645
Page 21 of 176
***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: 11091036 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/18/2020 16:47
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
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975646
Page 22 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975647
Page 23 of 176
***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: 11091036 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
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975648
Page 24 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975649
Page 25 of 176
***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: 11091036 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:
Oct/1/2020
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 [BMNG89]
5.bSample ID [BMNG8B]
5.cSample ID [BPXTLG]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975650
Page 26 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11091036 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:
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975651
Page 27 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11091036 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: [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975652
Page 28 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11091036 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 [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975653
Page 29 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11091036 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 [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975654
Page 30 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11091036 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?
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975655
Page 31 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11091036 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:
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975656
Page 32 of 176
***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: 11091036 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:
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975657
Page 33 of 176
***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: 11091036 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 [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975658
Page 34 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975659
Page 35 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Unplanned Assessments
1.Assessments
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975660
Page 36 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/1/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975661
Page 37 of 176
***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: 11091036 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: [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975662
Page 38 of 176
***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: 11091036 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:
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975663
Page 39 of 176
***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: 11091036 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 [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975664
Page 40 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
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).
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.
9.Is this event related to study treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication given?
12.Was a Non-Drug Treatment given?
13.What was the outcome of this adverse
event?:
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975665
Page 41 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975666
Page 42 of 176
***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: 11091036 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[ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975667
Page 43 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975668
Page 44 of 176
***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: 11091036 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: //
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975669
Page 45 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975670
Page 46 of 176
***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: 11091036 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?
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975671
Page 47 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975672
Page 48 of 176
***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: 11091036 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?
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975673
Page 49 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975674
Page 50 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975675
Page 51 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975676
Page 52 of 176
***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: 11091036 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:
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975677
Page 53 of 176
***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: 11091036 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:
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975678
Page 54 of 176
***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: 11091036 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?
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975679
Page 55 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975680
Page 56 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975681
Page 57 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled 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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975682
Page 58 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 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
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975683
Page 59 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/21/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975684
Page 60 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975685
Page 61 of 176
***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: 11091036 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: [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975686
Page 62 of 176
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975687
Page 63 of 176
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 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
Jan/27/2021
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975688
Page 64 of 176
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 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
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975689
Page 65 of 176
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 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 :Jan/27/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975690
Page 66 of 176
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 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: Jan/27/2021
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
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975691
Page 67 of 176
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 11091036 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:
Jan/27/2021
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 [BR7Y96]
5.bSample ID [BS37GM]
5.cSample ID [BS37GN]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975692
Page 68 of 176
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 11091036 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:
Jan/27/2021
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 [BR7Y93]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975693
Page 69 of 176
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 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: Jan/27/2021 09:53
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
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975694
Page 70 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975695
Page 71 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 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
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975696
Page 72 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 11091036 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/17/2021
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 [BRGKM7]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975697
Page 73 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 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/17/2021 09:26
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
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975698
Page 74 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975699
Page 75 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975700
Page 76 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975701
Page 77 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975702
Page 78 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975703
Page 79 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975704
Page 80 of 176
***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: 11091036 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: [ ]
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975705
Page 81 of 176
***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: 11091036 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 Oct/1/2020
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975706
Page 82 of 176
***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: 11091036 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
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975707
Page 83 of 176
***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: 11091036 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-08-2021 17:37:01 (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.
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975708
Page 84 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormAug-04-2020 12:42:44 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975709
Page 85 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aOct-05-2020 15:34:27 (UTC-05:00) Eastern Time
(US & Canada)Subject is postmenopausal since April 2003. unable
to add to the medical history page please thaw
6.aOct-05-2020 15:30:49 (UTC-05:00) Eastern Time
(US & Canada)postmenopausal since 2003please thaw medical
history page to allow us to add
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975710
Page 86 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aOct-05-2020 15:34:27 (UTC-05:00) Eastern Time
(US & Canada)Subject is postmenopausal since April 2003. unable
to add to the medical history page please thaw
6.aOct-05-2020 15:30:49 (UTC-05:00) Eastern Time
(US & Canada)postmenopausal since 2003please thaw medical
history page to allow us to add
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975711
Page 87 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aOct-05-2020 15:34:27 (UTC-05:00) Eastern Time
(US & Canada)Subject is postmenopausal since April 2003. unable
to add to the medical history page please thaw
6.aOct-05-2020 15:30:49 (UTC-05:00) Eastern Time
(US & Canada)postmenopausal since 2003please thaw medical
history page to allow us to add
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975712
Page 88 of 176
***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, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormJan-27-2021 13:49:52 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975713
Page 89 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormFeb-18-2021 09:56:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975714
Page 90 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Feb-18-2021 09:56:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975715
Page 91 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Feb-18-2021 09:56:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975716
Page 92 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Feb-18-2021 09:56:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975717
Page 93 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Feb-18-2021 09:56:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975718
Page 94 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Feb-18-2021 09:56:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975719
Page 95 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aFeb-18-2021 09:56:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975720
Page 96 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aFeb-18-2021 09:56:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975721
Page 97 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aFeb-18-2021 09:56:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975722
Page 98 of 176
***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: 11091036 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-08-2021 17:37:01 (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-18-2021 09:56:30 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin Approved Feb-03-2021 14:04:30 (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 Jan-27-2021 13:48:52 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin Approved Oct-12-2020 08:40:41 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975723
Page 99 of 176
***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: 11091036 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.
N/A Oct-01-2020 10:21:01 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin Approved Sep-11-2020 17:00:48 (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.
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975724
Page 100 of 176
***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: 11091036 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
Jul-30-2020 19:28:02
(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
Jul-30-2020 19:28:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975725
Page 101 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Jul-30-2020 19:28:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Jul/30/2020Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975726
Page 102 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject ID
Date Location User Value Reason
Jul-30-2020 16:53:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11091036Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Jul-30-2020 16:53:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1960Enrollment Entry
3. Sex:
Date Location User Value Reason
Jul-30-2020 19:31:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jul-30-2020 19:31:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Jul-30-2020 19:31:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975727
Page 103 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Jul-30-2020 19:31:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/30/2020Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975728
Page 104 of 176
***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: 11091036 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
Jul-30-2020 19:32:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jul-30-2020 19:32:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jul-30-2020 19:32:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975729
Page 105 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.a
Date Location User Value Reason
Jul-30-2020 19:33:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term: Acid Reflux
Start Date: Jan/1/2013
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jul-30-2020 19:33:05
(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
Jul-30-2020 19:33:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Acid RefluxInitial Entry
1.a Start Date:
Date Location User Value Reason
Jul-30-2020 19:33:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2013Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jul-30-2020 19:33:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Jul-30-2020 19:33:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Term: AsthmaInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975730
Page 106 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Start Date: Jan/1/2017
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Jul-30-2020 19:33:21
(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
Jul-30-2020 19:33:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
AsthmaInitial Entry
1.b Start Date:
Date Location User Value Reason
Jul-30-2020 19:33:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jul-30-2020 19:33:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Jul-31-2020 05:29:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 3
Medical History Ter
m:Bipolar Disord
er
Start Date: Jan/1/1985
Ongoing: YESChanged Information
Jul-30-2020 19:33:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:Bipolar MD
D
Start Date: Jan/1/1985Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975731
Page 107 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Ongoing: YES
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975732
Page 108 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.c Line/MH Number:
Date Location User Value Reason
Jul-30-2020 19:33:42
(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
Jul-31-2020
06:34:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Jul-31-2020
05:29:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Jul-31-2020
05:29:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Bipolar DisorderChanged
Information
Jul-31-2020
04:36:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Opened Clarify BIPOLAR
MDD as
follows...The term
is unclear. Are
you reporting
MAJOR
DEPRESSIVE
DISORDER?
MANIC
DEPRESSIVE
DISORDER? Or
BIPOLAR
DISORDER?
BIPOLAR I
DISORDER?
Other? If so, edit
the term as such.
Otherwise clarify
and edit the term
as appropriate.
Thank you.
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0975733
Page 109 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Jul-30-2020
19:33:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Bipolar MDDInitial Entry
1.c Start Date:
Date Location User Value Reason
Jul-30-2020 19:33:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/1985Initial Entry
1.c Ongoing:
Date Location User Value Reason
Jul-30-2020 19:33:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Jul-30-2020 19:33:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:Hypothyroidis
m
Start Date: Jan/1/2002
Ongoing: YESInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975734
Page 110 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.d Line/MH Number:
Date Location User Value Reason
Jul-30-2020 19:33:57
(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
Jul-30-2020 19:33:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypothyroidismInitial Entry
1.d Start Date:
Date Location User Value Reason
Jul-30-2020 19:33:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2002Initial Entry
1.d Ongoing:
Date Location User Value Reason
Jul-30-2020 19:33:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Jul-31-2020 05:30:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:5
Medical History
Term:Major Depressive
Disorder
Start Date: Jan/1/1985
Ongoing: YESChanged Information
Jul-31-2020 05:30:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:Major Depressive
Disorder
Start Date: UNK/UNK/1985
Ongoing: YESInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975735
Page 111 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.e Line/MH Number:
Date Location User Value Reason
Jul-31-2020 05:30:04
(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
Jul-31-2020 05:30:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Major Depressive DisorderInitial Entry
1.e Start Date:
Date Location User Value Reason
Jul-31-2020 05:30:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/1985Changed Information
Jul-31-2020 05:30:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.e Ongoing:
Date Location User Value Reason
Jul-31-2020 05:30:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975736
Page 112 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Jul-30-2020 19:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Jul-30-2020 19:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
162.4Initial Entry
3. Unit:
Date Location User Value Reason
Jul-30-2020 19:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Jul-30-2020 19:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Jul-30-2020 19:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Jul-30-2020 19:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.9Initial Entry
7.a
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975737
Page 113 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Jul-30-2020 19:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.9
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Jul-30-2020 19:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jul-30-2020 19:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.9Initial Entry
7.a Unit:
Date Location User Value Reason
Jul-30-2020 19:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Jul-30-2020 19:34:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975738
Page 114 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jul-30-2020 19:34:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jul-30-2020 19:34:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jul-30-2020 19:34:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/30/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jul-30-2020 19:34:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jul-30-2020 19:34:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jul-30-2020 19:34:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975739
Page 115 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Jul-30-2020 19:34:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jul-30-2020 19:34:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Jul-30-2020 19:34:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975740
Page 116 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Randomization Date :
Date Location User Value Reason
Jul-30-2020 19:35:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jul-31-2020 05:23:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
220717Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975741
Page 117 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-30-2020 19:35:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-30-2020 19:35:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jul-31-2020 07:51:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-30-2020 19:35:09
(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.
Jul-30-2020 19:35:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jul/30/2020Initial Entry
5.a
Date Location User Value Reason
Jul-31-2020 07:51:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLG8ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Jul-31-2020 07:51:18
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
BPLG8ZInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975742
Page 118 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada)
5.b
Date Location User Value Reason
Jul-31-2020 07:51:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLG90Initial Entry
5.b Sample ID
Date Location User Value Reason
Jul-31-2020 07:51:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPLG90Initial Entry
5.c
Date Location User Value Reason
Jul-31-2020 07:58:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLG91Initial Entry
5.c Sample ID
Date Location User Value Reason
Jul-31-2020 07:58:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPLG91Initial Entry
5.d
Date Location User Value Reason
Jul-31-2020 07:59:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLG92Initial Entry
5.d Sample ID
Date Location User Value Reason
Jul-31-2020 07:59:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPLG92Initial Entry
5.e
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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)
FDA-CBER-2021-5683-0975743
Page 119 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Jul-31-2020 08:11:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3R8ZInitial Entry
5.e Sample ID
Date Location User Value Reason
Jul-31-2020 08:11:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP3R8ZInitial Entry
5.f
Date Location User Value Reason
Jul-31-2020 08:11:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3R90Initial Entry
5.f Sample ID
Date Location User Value Reason
Jul-31-2020 08:11:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP3R90Initial Entry
5.g
Date Location User Value Reason
Jul-31-2020 08:11:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3R91Initial Entry
5.g Sample ID
Date Location User Value Reason
Jul-31-2020 08:11:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP3R91Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975744
Page 120 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-30-2020 19:35:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-30-2020 19:35:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jul-31-2020 07:35:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-30-2020 19:35:15
(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.
Jul-30-2020 19:35:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jul/30/2020Initial Entry
5.a
Date Location User Value Reason
Jul-31-2020 07:35:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3R92Initial Entry
5.a Sample ID
Date Location User Value Reason
Jul-31-2020 07:35:51
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
BP3R92Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975745
Page 121 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada)
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975746
Page 122 of 176
***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: 11091036 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
Jul-30-2020 19:35:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jul-30-2020 19:35:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jul-30-2020 19:35:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jul-30-2020 19:35:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/30/2020 16:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jul-30-2020 19:35:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jul-30-2020 19:35:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975747
Page 123 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Jul-30-2020 19:35:36
(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
Jul-30-2020 19:35:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Jul-30-2020 19:35:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975748
Page 124 of 176
***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: 11091036 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
Jul-30-2020 19:35:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DIAR
Y COLLECTED FOR THIS SUBJE
CTInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975749
Page 125 of 176
***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: 11091036 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-19-2020 09:02:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975750
Page 126 of 176
***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: 11091036 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-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-19-2020 09:03:34
(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-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975751
Page 127 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.b Symptom:
Date Location User Value Reason
Aug-19-2020 09:03:34
(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-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Aug-19-2020 09:03:34
(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-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CHInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975752
Page 128 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
ILL
S
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Aug-19-2020 09:03:34
(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-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-19-2020 09:03:34
(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-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975753
Page 129 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.f
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Aug-19-2020 09:03:34
(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-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975754
Page 130 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.g Symptom:
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE PA
INInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975755
Page 131 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada)
4. Injection Site Body Side:
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-19-2020 09:03:34
(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-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975756
Page 132 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-19-2020 09:03:34
(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-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SIT
E
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-19-2020 09:03:34
(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-19-2020 09:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975757
Page 133 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Aug-19-2020 09:04:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2.a
Date Location User Value Reason
Aug-19-2020 09:04:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.6
Temperature Unit: F
Temperature Locatio
n::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-19-2020 09:04:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-19-2020 09:04:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.6Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-19-2020 09:04:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Aug-19-2020 09:04:03
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0975758
Page 134 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada)
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975759
Page 135 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-19-2020 09:04:38
(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-19-2020 09:04:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-19-2020 09:04:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-19-2020 09:04:38
(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-19-2020 09:04:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-08-2020 09:21:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVEChanged Information
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975760
Page 136 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Not Done::
Oct-05-2020 17:12:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done:: NOT DONEInitial Entry
Aug-19-2020 09:04:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-19-2020 09:04:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-19-2020 09:04:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-05-2020 17:12:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-09-2020 05:34:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975761
Page 137 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Oct-08-2020 09:21:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Answer Auto Query
Oct-08-2020 09:21:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Changed Information
Oct-06-2020 08:12:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM: Per CRF
completion, data for
both result and not
done is not applicable.
Please verify and
update data for either
result or not done, else
clarify.
Oct-06-2020 08:12:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-05-2020 17:14:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Result was
inadvertently not
entered. Updated now.
Oct-05-2020 17:14:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Please unlock to
correct. Result was
inadvertently not
entered.
Oct-05-2020 17:12:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Not Done is indicated
however result is
provided. Please
correct or clarify.
Oct-05-2020 04:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: V2: Please
can you confirm why
a pregnancy test was
not done for this
subject? there is
nothing in her medhx
to indicate she is not a
woman of child
bearing potential.
Thanks
Aug-19-2020 09:04:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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)
FDA-CBER-2021-5683-0975762
Page 138 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 07:33:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 07:33:17
(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-19-2020 07:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020 07:33:17
(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-19-2020 07:33:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020 07:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXRW4Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-19-2020 07:33:28
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
BPXRW4Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0975763
Page 139 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada)
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975764
Page 140 of 176
***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: 11091036 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-19-2020 09:05:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-19-2020 09:05:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-19-2020 09:05:21
(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-19-2020 09:05:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020 16:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-19-2020 09:05:21
(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-19-2020 09:05:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975765
Page 141 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-19-2020 09:05:21
(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-19-2020 09:05:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-19-2020 09:05:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975766
Page 142 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User ValueReason
Oct-09-2020
12:53:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Oct-09-2020
11:09:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredPD written and filed.
Oct-08-2020
15:01:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 9 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately.
Oct-01-2020
10:21:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Oct/1/
2020Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0975767
Page 143 of 176
***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: 11091036 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
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-01-2020 10:21:33
(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
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975768
Page 144 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.b Symptom:
Date Location User Value Reason
Oct-01-2020 10:21:33
(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
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was comple
ted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Oct-01-2020 10:21:33
(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
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CHInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975769
Page 145 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
ILL
S
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NO
2.d Symptom:
Date Location User Value Reason
Oct-01-2020 10:21:33
(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
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was comple
ted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-01-2020 10:21:33
(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
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975770
Page 146 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.f
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Oct-01-2020 10:21:33
(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
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975771
Page 147 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.g Symptom:
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic
symptoms present on th
e last day the Subject Di
ary was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975772
Page 148 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada)
4. Injection Site Body Side:
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions p
resent on the last day the Sub
ject Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020 10:21:33
(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
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions
present on the last day the S
ubject Diary was completed?
:NOInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975773
Page 149 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020 10:21:33
(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
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SIT
E
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020 10:21:33
(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
Oct-01-2020 10:21:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975774
Page 150 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 10:21:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 10:21:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020 14:20:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-01-2020 10:21:48
(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.
Oct-01-2020 10:21:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020 14:20:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMNG89Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-01-2020 14:20:27
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
BMNG89Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0975775
Page 151 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada)
5.b
Date Location User Value Reason
Oct-01-2020 14:20:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMNG8BInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-01-2020 14:20:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BMNG8BInitial Entry
5.c
Date Location User Value Reason
Oct-01-2020 14:33:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXTLGInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-01-2020 14:33:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPXTLGInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975776
Page 152 of 176
***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: 11091036 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
Oct-01-2020 10:22:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-01-2020 10:22:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-01-2020 10:22:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975777
Page 153 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled 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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-27-2021 13:48:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/21/2021Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975778
Page 154 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 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
Jan-27-2021 13:49:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-27-2021 13:48:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Jan-27-2021 13:48:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for Vac
cination 3
Participant is:
eligible per local/national recomme
ndations and confirmed to have rec
eived only placebo at Vaccination 1
/2Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975779
Page 155 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-27-2021 13:49:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/21/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-27-2021 13:49:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR ADDITI
ONAL VACCINATIONInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975780
Page 156 of 176
***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, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-27-2021 13:49:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/27/2021Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975781
Page 157 of 176
***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, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-27-2021 13:49:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/27/2021Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975782
Page 158 of 176
***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, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 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
Jan-27-2021 13:50:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/27/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-27-2021 13:50:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-27-2021 13:50:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975783
Page 159 of 176
***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, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-27-2021 13:50:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-27-2021 13:50:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-27-2021 13:50:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/27/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-27-2021 13:50:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-27-2021 13:50:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jan-27-2021 13:50:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975784
Page 160 of 176
***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, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Jan-27-2021 13:50:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-27-2021 13:50:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Jan-27-2021 13:50:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975785
Page 161 of 176
***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, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021 13:50:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021 13:50:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-29-2021 07:32:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-28-2021 04:12:39
(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.
Jan-27-2021 13:50:35
(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.
Jan-27-2021 13:50:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/27/2021Initial Entry
5.a
Date Location User Value Reason
Jan-29-2021 07:32:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR7Y96Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975786
Page 162 of 176
***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, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.a Sample ID
Date Location User Value Reason
Jan-29-2021 07:32:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR7Y96Initial Entry
5.b
Date Location User Value Reason
Jan-29-2021 07:33:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS37GMInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-29-2021 07:33:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BS37GMInitial Entry
5.c
Date Location User Value Reason
Jan-29-2021 07:33:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS37GNInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-29-2021 07:33:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BS37GNInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975787
Page 163 of 176
***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, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021 13:50:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021 13:50:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021 15:34:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-27-2021 13:50:46
(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.
Jan-27-2021 13:50:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/27/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021 15:34:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR7Y93Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-27-2021 15:34:15
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
BR7Y93Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0975788
Page 164 of 176
***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, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada)
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0975789
Page 165 of 176
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 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
Jan-27-2021 13:51:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-27-2021 13:51:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-27-2021 13:51:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-27-2021 13:51:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/27/2021 09:53Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-27-2021 13:51:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-27-2021 13:51:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975790
Page 166 of 176
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Jan-27-2021 13:51:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-27-2021 13:51:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-27-2021 13:51:11
(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
Jan-27-2021 13:51:11
(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
Jan-27-2021 13:51:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975791
Page 167 of 176
***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, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 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-18-2021 09:56:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/17/2021Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975792
Page 168 of 176
***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, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-18-2021 09:56:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-18-2021 09:56:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-18-2021 09:56:50
(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-18-2021 09:56:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-18-2021 09:56:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Feb-18-2021 09:56:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defined Ident
ifier:Not Applica
ble
Test:: Not Applica
bleInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (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-2021-5683-0975793
Page 169 of 176
***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, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Result:: Not Applica
ble
Not Done:: Not Applica
ble
6.a Sponsor ID:
Date Location User Value Reason
Feb-18-2021 09:56:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Feb-18-2021 09:56:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Feb-18-2021 09:56:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Feb-18-2021 09:56:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975794
Page 170 of 176
***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, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-18-2021 09:57:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-18-2021 09:57:07
(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-22-2021 06:56:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-19-2021 06:24:15
(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-18-2021 09:57:07
(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-18-2021 09:57:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/17/2021Initial Entry
5.a
Date Location User Value Reason
Feb-22-2021 06:56:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRGKM7Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975795
Page 171 of 176
***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, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.a Sample ID
Date Location User Value Reason
Feb-22-2021 06:56:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BRGKM7Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975796
Page 172 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 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-18-2021 10:00:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-18-2021 10:00:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-18-2021 10:00:20
(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-18-2021 10:00:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/17/2021 09:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-18-2021 10:00:20
(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-18-2021 10:00:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975797
Page 173 of 176
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Feb-18-2021 10:00:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-18-2021 10:00:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-18-2021 10:00:20
(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-18-2021 10:00:20
(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-18-2021 10:00:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975798
Page 174 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-01-2020 10:22:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Jul-30-2020 19:35:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Jul-30-2020 19:32:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-01-2021 13:48:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-01-2021 08:23:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Confirm
Feb-01-2021 02:47:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened RQ1: Response states
'Subject had allergies'.
Please confirm if
Illness ediary entry on
23JAN2021 was
deemed erroneous and
that subject had no
Covid Illness
symptoms.
Jan-29-2021 18:04:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject had allergies
Jan-28-2021 15:15:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Illness eDiary:
Subject reported
"Yes" for the question
"Have you
experienced any of
the following?” for
the COVID-19
symptoms or
diagnosis on
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0975799
Page 175 of 176
***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: 11091036 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
23JAN2021. But
there is no COVID
Illness visit reported
in the database. Please
clarify.
Oct-01-2020 10:22:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/1/2020Initial Entry
Jul-30-2020 19:35:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Jul/30/2020Initial Entry
Jul-30-2020 19:32:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Jul/30/2020Initial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0975800
Page 176 of 176
***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: 11091036 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 16:07:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3ee2\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0975801