Document text
Page 1 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is
equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895760
Page 2 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/12/2020
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895761
Page 3 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10191021]
2.Birth Date: 1938
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895762
Page 4 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/12/2020
2.Erroneous Visit
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895763
Page 5 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Inclusion Criteria Not Met
1.aDescription of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895764
Page 6 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895765
Page 7 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Cataract Left Eye]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2015
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Cataract right Eye]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2017
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Presbyopia]
Start Date: UNK/UNK/2005
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: UNK/UNK/2000
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2008
Ongoing: YES
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895766
Page 8 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Arterial Peripheral vascular disease]
Start Date: Mar/1/2007
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Coronary artery disease]
Start Date: UNK/UNK/2006
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Peripheral Artery Disease]
Start Date: Mar/1/2007
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Gastric Reflux]
Start Date: May/10/2000
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Fracture right 5th finger]
Start Date: Jul/9/2014
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[recurrent left leg pain]
Start Date: Mar/UNK/2016
Ongoing: NO
End Date:
Jun/UNK/2016
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895767
Page 9 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Diabetes Type II]
Start Date: Feb/10/1999
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypothyroidism]
Start Date: UNK/UNK/1999
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Iron Deficiency Anemia]
Start Date: Jan/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2013
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Vicodin Allergy]
Start Date: UNK/UNK/2007
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Left Femoral popliteal bypass]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Coronary angioplasty]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895768
Page 10 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Carotid endarterectomy]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Cataract surgery left eye]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Cataract surgery right eye]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Post Menopausal]
Start Date: UNK/UNK/1982
Ongoing: YES
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Myopia]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895769
Page 11 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/12/2020
2.Weight: [141.9]
3.Unit: LB
4.Height: [63.0]
5.Unit: in
6.Body Mass Index: [25.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: EAR
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895770
Page 12 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/12/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895771
Page 13 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/12/2020
2.Randomization Number: [226751]
3.Randomization Group: [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895772
Page 14 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
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 [BM86D4]
5.bSample ID [BM86D5]
5.cSample ID [BM86D6]
5.dSample ID [BPRM3Z]
5.eSample ID [BPRM40]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895773
Page 15 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
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 [BM85ZZ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895774
Page 16 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/12/2020 12:28
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
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895775
Page 17 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895776
Page 18 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895777
Page 19 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895778
Page 20 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895779
Page 21 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.0]
Unit: F
Temperature Location: EAR
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895780
Page 22 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/2/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895781
Page 23 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM864S]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895782
Page 24 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/2/2020 10:27
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
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895783
Page 25 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895784
Page 26 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895785
Page 27 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895786
Page 28 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP98HG]
5.bSample ID [BPRWX4]
5.cSample ID [BPRWX5]
5.dSample ID [BPRWX6]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895787
Page 29 of 174
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895788
Page 30 of 174
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895789
Page 31 of 174
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895790
Page 32 of 174
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895791
Page 33 of 174
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895792
Page 34 of 174
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895793
Page 35 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895794
Page 36 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895795
Page 37 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895796
Page 38 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895797
Page 39 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
1.Physician or Healthcare Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due to
potential COVID-19 illness?
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895798
Page 40 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895799
Page 41 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895800
Page 42 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895801
Page 43 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895802
Page 44 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895803
Page 45 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895804
Page 46 of 174
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Feb/22/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: PROTOCOL DEVIATION
4.Specify Status: [Subject received other Coronavirus vaccine elsewhere.]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895805
Page 47 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895806
Page 48 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895807
Page 49 of 174
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identifie
rAdverse Even
tStart DateIs the Adverse Event Still Ongoi
ngForm Instance
1.ADVERSE EVEN
T 1 Pancreatitis Dec/30/2020 UNK:UN
K NO
End Date Time:
Jan/4/2021 UNK:UNK
Repeating Pages
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895808
Page 50 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pancreatitis]
4.Start Date Time: Dec/30/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/4/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[IDIOPATHIC]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895809
Page 51 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021026425]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895810
Page 52 of 174
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Actio
nForm Instance
1. [ ] Repeating Pages
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895811
Page 53 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of Medication
Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895812
Page 54 of 174
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of MedicationStart Da
teForm Instance
1.1 VACCINATIONS NO Moderna COVID-19 V
accine Feb/4/20
21 Repeating
Pages
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895813
Page 55 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications Pre-specified: NO
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).[Moderna COVID-19 Vaccine]
5.Date: Feb/4/2021
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895814
Page 56 of 174
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionDose Descrip
tionForm Instance
1.[ ] [ ] [ ] Repeating
Pages
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895815
Page 57 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895816
Page 58 of 174
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895817
Page 59 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895818
Page 60 of 174
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895819
Page 61 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895820
Page 62 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895821
Page 63 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895822
Page 64 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895823
Page 65 of 174
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895824
Page 66 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895825
Page 67 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895826
Page 68 of 174
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895827
Page 69 of 174
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895828
Page 70 of 174
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895829
Page 71 of 174
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895830
Page 72 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895831
Page 73 of 174
***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, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895832
Page 74 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/22/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895833
Page 75 of 174
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895834
Page 76 of 174
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895835
Page 77 of 174
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895836
Page 78 of 174
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895837
Page 79 of 174
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
Met
Exclusion Criteria Met
2.Description of Exclusion Criterion
Met
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895838
Page 80 of 174
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895839
Page 81 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Feb/22/2021
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895840
Page 82 of 174
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895841
Page 83 of 174
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895842
Page 84 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-18-2020 08:03:13 (UTC-06:00) Central Time
(US & Canada)N/A
FormAug-13-2020 12:10:37 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895843
Page 85 of 174
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-25-2021 08:49:31 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 18:07:29 (UTC-06:00) Central Time (US
& Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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-13-2021 15:59:40 (UTC-06:00) Central Time (US
& Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-12-2020 12:20:27 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Sep-30-2020 09:35:14 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895844
Page 86 of 174
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Approved Sep-15-2020 15:46:25 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895845
Page 87 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-12-2020 14:19:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-12-2020 14:19:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895846
Page 88 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-12-2020 14:20:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/12/2020Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895847
Page 89 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-12-2020 14:19:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10191021Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-12-2020 14:19:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1938Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-12-2020 14:20:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-12-2020 14:20:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR OF SPA
NISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-12-2020 14:20:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895848
Page 90 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-12-2020 14:20:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895849
Page 91 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-12-2020 14:20:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Criterion Description:Transcription Error
Aug-12-2020 14:20:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Crite
rion
Desc
ripti
on:Male or female participants betw
een the ages of 18 and 55 years, i
nclusive, 65 and 85 years, inclusi
ve, or 18 and 85 years, inclusive,
at randomization (dependent upo
n study phase)Initial Entry
1.a Description of Inclusion Criterion Not Met
Date Location User Value Reason
Aug-19-2020 08:43:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed by DM:
Aug-18-2020 08:03:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered completed
Aug-17-2020 13:32:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM query: Thank you
for your response,
however there is no
Form level comment. A
form level comment is
located across from the
title. Please review and
update appropriate.
Aug-13-2020 12:10:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Aug-13-2020 06:16:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened As per Protocol
Amendment 5
(24Jul2020). INC EXC
form is not applicable.
Please add Form level
comment as “Not
Applicable”
Aug-12-2020 14:20:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0895850
Page 92 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-12-2020 14:20:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Male or female participants between th
e ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 ye
ars, inclusive, at randomization (depend
ent upon study phase)Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895851
Page 93 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-12-2020 14:21:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-12-2020 14:21:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-12-2020 14:21:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895852
Page 94 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-12-2020 14:23:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Cataract Left Eye
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/20
15Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:23:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:23:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Cataract Left EyeInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-12-2020 14:23:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-12-2020 14:23:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.b
Date Location User Value Reason
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895853
Page 95 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-12-2020 14:24:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:Cataract right Eye
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/20
17Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:24:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:24:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Cataract right EyeInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-12-2020 14:24:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-12-2020 14:24:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.c
Date Location User Value Reason
Aug-12-2020 14:25:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Term
:PresbyopiaInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895854
Page 96 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/200
5
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:25:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:25:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PresbyopiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-12-2020 14:25:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-12-2020 14:25:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-12-2020 14:26:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Term
:Hypertension
Start Date: UNK/UNK/200
0
Ongoing: YESInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895855
Page 97 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:26:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:26:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-12-2020 14:26:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-12-2020 14:26:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-12-2020 14:26:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:Hypercholesterole
mia
Start Date: UNK/UNK/2008
Ongoing: YESInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895856
Page 98 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:26:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:26:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypercholesterolemiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-12-2020 14:26:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-12-2020 14:26:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-20-2020 08:20:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:Arterial Peripheral vas
cular disease
Start Date: Mar/1/2007
Ongoing: YESTranscription Error
Aug-12-2020 14:27:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:Peripheral vascular
disease
Start Date: Mar/1/2007
Ongoing: YESInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895857
Page 99 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:27:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 21:10:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-20-2020 08:20:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Aug-20-2020 08:20:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Arterial Peripheral vascular diseaseTranscription Error
Aug-17-2020 20:44:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened please can arterial be
added to Med Hx term
Aug-14-2020 08:34:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered arterial per PI
Aug-13-2020 18:48:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Please specify whether
the peripheral vascular
disease is arterial or
venous and update the
reported term
accordingly.
Aug-12-2020 14:27:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Peripheral vascular diseaseInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-12-2020 14:27:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/1/2007Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-12-2020 14:27:07
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0895858
Page 100 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
1.g
Date Location User Value Reason
Aug-12-2020 14:27:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Te
rm:Coronary artery dis
ease
Start Date: UNK/UNK/2006
Ongoing: YESInitial Entry
1.g Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:27:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:27:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Coronary artery diseaseInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-12-2020 14:27:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2006Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-12-2020 14:27:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-12-2020 14:42:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:8
Medical History T
erm:Peripheral Artery Di
seaseInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895859
Page 101 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: Mar/1/2007
Ongoing: YES
Aug-12-2020 14:31:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number:
Medical History Term:
Start Date: Mar/1/2007
Ongoing: YESTranscription Error
Aug-12-2020 14:30:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:8
Medical History T
erm:Peripheral Artery di
sease
Start Date: Mar/1/2007
Ongoing: YESInitial Entry
1.h Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:42:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
Aug-12-2020 14:31:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Aug-12-2020 14:30:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:42:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Peripheral Artery DiseaseInitial Entry
Aug-12-2020 14:31:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895860
Page 102 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:30:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Peripheral Artery diseaseInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-12-2020 14:30:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/1/2007Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-12-2020 14:30:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-12-2020 14:43:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Term: Gastric Reflux
Start Date: May/10/2000
Ongoing: YESInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895861
Page 103 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:43:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:43:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Gastric RefluxInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-12-2020 14:43:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
May/10/2000Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-12-2020 14:43:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-12-2020 14:43:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Te
rm:Fracture right 5th fi
nger
Start Date: Jul/9/2014
Ongoing: YESInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895862
Page 104 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:43:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:43:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Fracture right 5th fingerInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-12-2020 14:43:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/9/2014Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-12-2020 14:43:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Aug-12-2020 14:44:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 11
Medical History Ter
m:recurrent left leg p
ain
Start Date: Mar/UNK/2016
Ongoing: NO
End Date:
Jun/UNK/2016Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895863
Page 105 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.k Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:44:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:44:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
recurrent left leg painInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-12-2020 14:44:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/UNK/2016Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-12-2020 14:44:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jun/UNK/2016Initial Entry
1.l
Date Location User Value Reason
Aug-12-2020 14:45:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 12
Medical History Term
:Diabetes Type I
I
Start Date: Feb/10/1999
Ongoing: YESInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895864
Page 106 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.l Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:45:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:45:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Diabetes Type IIInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-12-2020 14:45:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/10/1999Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-12-2020 14:45:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Aug-12-2020 14:46:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 13
Medical History Term
:Hypothyroidism
Start Date: UNK/UNK/199
9
Ongoing: YESInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895865
Page 107 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.m Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:46:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:46:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypothyroidismInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-12-2020 14:46:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1999Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-12-2020 14:46:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Aug-12-2020 14:46:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 14
Medical History T
erm:Iron Deficiency Ane
mia
Start Date: Jan/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2013Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895866
Page 108 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.n Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:46:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:46:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Iron Deficiency AnemiaInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-12-2020 14:46:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2011Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-12-2020 14:46:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.o
Date Location User Value Reason
Aug-12-2020 14:47:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 15
Medical History Term
:Vicodin Allergy
Start Date: UNK/UNK/200
7
Ongoing: YESInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895867
Page 109 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.o Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:47:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:47:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Vicodin AllergyInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-12-2020 14:47:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2007Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-12-2020 14:47:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Aug-12-2020 14:48:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:16
Medical History
Term:Left Femoral popliteal
bypass
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895868
Page 110 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.p Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:48:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:48:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Left Femoral popliteal bypassInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-12-2020 14:48:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2006Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-12-2020 14:48:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2006Initial Entry
1.q
Date Location User Value Reason
Aug-12-2020 14:48:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 17
Medical History Te
rm:Coronary angiopla
sty
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/200
7Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895869
Page 111 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.q Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:48:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:48:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Coronary angioplastyInitial Entry
1.q Start Date:
Date Location User Value Reason
Aug-12-2020 14:48:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2007Initial Entry
1.q Ongoing:
Date Location User Value Reason
Aug-12-2020 14:48:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2007Initial Entry
1.r
Date Location User Value Reason
Aug-12-2020 14:49:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number
:18
Medical History T
erm:Carotid endarterect
omy
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/200
9Transcription Error
Aug-12-2020 14:49:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:18Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895870
Page 112 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History T
erm:CAortid endarterect
omy
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/200
9
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895871
Page 113 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.r Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:49:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:49:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Carotid endarterectomyTranscription Error
Aug-12-2020 14:49:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CAortid endarterectomyInitial Entry
1.r Start Date:
Date Location User Value Reason
Aug-12-2020 14:49:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.r Ongoing:
Date Location User Value Reason
Aug-12-2020 14:49:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.s
Date Location User Value Reason
Aug-12-2020 14:49:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 19
Medical History T
erm:Cataract surgery left
eye
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895872
Page 114 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.s Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:49:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:49:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Cataract surgery left eyeInitial Entry
1.s Start Date:
Date Location User Value Reason
Aug-12-2020 14:49:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.s Ongoing:
Date Location User Value Reason
Aug-12-2020 14:49:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.t
Date Location User Value Reason
Aug-12-2020 14:50:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:20
Medical History T
erm:Cataract surgery righ
t eye
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895873
Page 115 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.t Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:50:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
20Initial Entry
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:50:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Cataract surgery right eyeInitial Entry
1.t Start Date:
Date Location User Value Reason
Aug-12-2020 14:50:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.t Ongoing:
Date Location User Value Reason
Aug-12-2020 14:50:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.u
Date Location User Value Reason
Aug-12-2020 14:50:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 21
Medical History Term
:Post Menopausa
l
Start Date: UNK/UNK/198
2
Ongoing: YESInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895874
Page 116 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.u Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:50:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
21Initial Entry
1.u Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:50:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Post MenopausalInitial Entry
1.u Start Date:
Date Location User Value Reason
Aug-12-2020 14:50:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1982Initial Entry
1.u Ongoing:
Date Location User Value Reason
Aug-12-2020 14:50:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.v
Date Location User Value Reason
Aug-12-2020 14:50:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 22
Medical History Term
:Myopia
Start Date: UNK/UNK/201
7
Ongoing: YESInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895875
Page 117 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.v Line/MH Number:
Date Location User Value Reason
Aug-12-2020 14:50:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22Initial Entry
1.v Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 14:50:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MyopiaInitial Entry
1.v Start Date:
Date Location User Value Reason
Aug-12-2020 14:50:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.v Ongoing:
Date Location User Value Reason
Aug-12-2020 14:50:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895876
Page 118 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-12-2020 14:52:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-12-2020 14:52:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
141.9Initial Entry
3. Unit:
Date Location User Value Reason
Aug-12-2020 14:52:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-12-2020 14:53:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
63.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-12-2020 14:52:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-12-2020 14:53:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.1Initial Entry
Aug-12-2020 14:52:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
7.a
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895877
Page 119 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-12-2020 14:52:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.4
Temperature Unit: F
Temperature Location:: EARInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-12-2020 14:52:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-12-2020 14:52:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-12-2020 14:52:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-12-2020 14:52:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EARInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895878
Page 120 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-12-2020 14:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-12-2020 14:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-12-2020 14:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-12-2020 14:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-12-2020 14:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-12-2020 14:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895879
Page 121 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a Sponsor ID:
Date Location User Value Reason
Aug-12-2020 14:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-12-2020 14:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-12-2020 14:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895880
Page 122 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-12-2020 14:54:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-12-2020 14:54:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
226751Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895881
Page 123 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020 15:21:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020 15:21:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020 15:22:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-12-2020 15:21:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-12-2020 15:21:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
Aug-12-2020 15:22:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM86D4Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-12-2020 15:22:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM86D4Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895882
Page 124 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b
Date Location User Value Reason
Aug-12-2020 15:22:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM86D5Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-12-2020 15:22:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM86D5Initial Entry
5.c
Date Location User Value Reason
Aug-12-2020 15:22:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM86D6Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-12-2020 15:22:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM86D6Initial Entry
5.d
Date Location User Value Reason
Aug-12-2020 15:22:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRM3ZInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-12-2020 15:22:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPRM3ZInitial Entry
5.e
Date Location User Value Reason
Aug-12-2020 15:23:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRM40Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895883
Page 125 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.e Sample ID
Date Location User Value Reason
Aug-12-2020 15:23:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPRM40Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895884
Page 126 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020 15:19:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020 15:19:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020 15:21:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-12-2020 15:19:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-12-2020 15:19:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
Aug-12-2020 15:21:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM85ZZInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-12-2020 15:21:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM85ZZInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895885
Page 127 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-12-2020 14:55:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-12-2020 14:55:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-12-2020 14:55:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-21-2020 04:38:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-20-2020 14:03:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered subject reported
incorrect temperature
values in diary entries.
Subject was contacted
today and reported
normal temperatures.
Subject reported
feeling well.
Aug-18-2020 12:48:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened eDiary: Per eDiary
records, e-Diary
Temperature value(s)
recorded is < 94 F
(34.4 C). Please
confirm if the
thermometer recording
from subject or the
entry is appropriate.
Thanks.
Aug-12-2020 14:55:32 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895886
Page 128 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central Time
(US & Canada)Aug/12/2020 12:28
5. Anatomical Location:
Date Location User Value Reason
Aug-12-2020 14:55:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-12-2020 14:55:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-12-2020 14:55:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-12-2020 14:55:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION 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-12-2020 14:55:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0895887
Page 129 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-12-2020 14:55:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DIARY
COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895888
Page 130 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020 12:43:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895889
Page 131 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symptoms
present on the last day the Subjec
t Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic symptom
s present on the last day the Subj
ect Diary was completed?:NOInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895890
Page 132 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.b Symptom:
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
ILL
SInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895891
Page 133 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were fever or systemic symptom
s present on the last day the Subj
ect Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895892
Page 134 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) Symptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.f Symptom:
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSENE
D MUSCL
E PAIN
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895893
Page 135 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central 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
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RED
NES
SInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895894
Page 136 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were injection site reactions pre
sent on the last day the Subject
Diary was completed?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions pr
esent on the last day the Subjec
t Diary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895895
Page 137 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 12:44:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895896
Page 138 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020 12:45:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2.a
Date Location User Value Reason
Sep-02-2020 12:45:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 96.0
Temperature Unit: F
Temperature Location:: EARInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-02-2020 12:45:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-02-2020 14:57:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-02-2020 12:46:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered NCS per PI
Sep-02-2020 12:45:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 96 F is
outside of Normal
Range 97 - 99.5 F.
Sep-02-2020 12:45:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
96.0Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-02-2020 12:45:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895897
Page 139 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.a Temperature Location:
Date Location User Value Reason
Sep-02-2020 12:45:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EARInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895898
Page 140 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-02-2020 12:45:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-02-2020 12:45:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-02-2020 12:45:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-02-2020 12:45:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-02-2020 12:45:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-02-2020 12:45:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895899
Page 141 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a Sponsor ID:
Date Location User Value Reason
Sep-02-2020 12:45:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-02-2020 12:45:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-02-2020 12:45:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895900
Page 142 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 11:36:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 11:36:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 11:36:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 11:36:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-02-2020 11:36:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020 11:36:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM864SInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 11:36:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM864SInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895901
Page 143 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-02-2020 12:46:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020 12:46:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020 12:46:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-02-2020 12:46:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020 10:27Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020 12:46:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-02-2020 12:46:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-02-2020 12:46:10 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895902
Page 144 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central Time
(US & Canada)(autocalc) INTRAMUSCULAR
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-02-2020 12:46:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-02-2020 12:46:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895903
Page 145 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020 09:35:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895904
Page 146 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symptoms
present on the last day the Subjec
t Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic symptom
s present on the last day the Subj
ect Diary was completed?:NOInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895905
Page 147 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.b Symptom:
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
ILL
SInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895906
Page 148 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were fever or systemic symptom
s present on the last day the Subj
ect Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0895907
Page 149 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) Symptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.f Symptom:
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSENE
D MUSCL
E PAIN
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895908
Page 150 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central 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
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RED
NES
SInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895909
Page 151 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were injection site reactions pre
sent on the last day the Subject
Diary was completed?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions pr
esent on the last day the Subjec
t Diary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0895910
Page 152 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 09:35:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0895911
Page 153 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020 10:48:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020 10:48:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-30-2020 10:48:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-30-2020 10:48:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-30-2020 10:48:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Sep-30-2020 10:48:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP98HGInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-30-2020 10:48:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP98HGInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895912
Page 154 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b
Date Location User Value Reason
Sep-30-2020 10:48:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRWX4Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-30-2020 10:48:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPRWX4Initial Entry
5.c
Date Location User Value Reason
Sep-30-2020 10:48:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRWX5Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-30-2020 10:48:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPRWX5Initial Entry
5.d
Date Location User Value Reason
Sep-30-2020 10:48:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRWX6Initial Entry
5.d Sample ID
Date Location User Value Reason
Sep-30-2020 10:48:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPRWX6Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0895913
Page 155 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-30-2020 09:54:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-30-2020 09:54:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-30-2020 09:54:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895914
Page 156 of 174
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-25-2021 08:56:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/22/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-25-2021 08:56:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Mar-12-2021 14:37:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 2: Closed Response satisfies
query
Mar-12-2021 13:38:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed Information
Mar-12-2021 13:38:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PROTOCOL DEVIATIONChanged Information
Mar-04-2021 00:19:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINQUERY: Please
review status selection
based on receipt of
covid-19 vaccine per
CCRs, vers 14, FAQ#5,
p228 and update as
appropriate
Mar-03-2021 17:21:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 2: Candidate CLINQUERY: Please
review status selection
based on receipt of
covid-19 vaccine per
CCRs, vers 14, FAQ#5,
p228 and update as
appropriate
Feb-25-2021 08:56:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-25-2021 08:56:13 ACV0PFEINFP6000 auto query Query 1: Opened Response to "Status" is
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0895915
Page 157 of 174
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central Time
(US & Canada)(autoquery) NO LONGER MEETS
ELIGIBILITY
CRITERIA but
"Specify Status" is
missing.
Feb-25-2021 08:56:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO LONGER MEETS ELIGIBILITY C
RITERIAInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-04-2021 12:13:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Closed Response satisfies
query
Mar-04-2021 11:46:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Conmed Vax log
updated.
Mar-03-2021 17:23:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Opened CLINQUERY: Please
review if the non-study
vax was received prior
to study end. If so,
please capture on
Conmed Vax log, incl
manufacturer
Feb-25-2021 08:56:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Subject received other Coronavirus vacc
ine elsewhere.Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0895916
Page 158 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Jan-13-2021 15:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895917
Page 159 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Jan-13-2021 15:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-13-2021 15:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-09-2021 00:30:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies query
Mar-09-2021 00:09:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 5: Closed Response satisfies query
Mar-08-2021 07:23:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Answered New Information
Mar-08-2021 07:23:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Answered New Information
Mar-08-2021 07:23:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PancreatitisNew Information
Mar-08-2021 04:30:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 5: Opened SAE RECON:
AER#2021026425,the
term was updated to
'pancreatitis' in Safety
database while recorded
as 'Pancreatic Cyst' in
AE CRF. Please confirm
correct term.If safety
update is required, please
submit a follow-up form.
Mar-05-2021 09:51:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: Opened Clinical With receipt of
Med Records (with
COVID test), please
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895918
Page 160 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
submit a SAE safety
update with the method
that discovered the
pancreatic cyst, whether
it was an incidental
finding or symptomatic
event, & reason for
hospitalization
Mar-05-2021 09:50:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies query
Mar-04-2021 08:45:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answered SAE F/U has been
submitted.
Feb-23-2021 12:51:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Query closed; will
follow for requested
clinical presentation
information.
Feb-23-2021 12:50:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical - please submit
the relevant Medical
History from the study
day 1 CRF; including
T2DM, hypothyroid, and
any other relevant Med
Hx to the SAE Med Hx
section, in a SAE safety
update
Feb-23-2021 12:49:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Clinical - please submit
the relevant Medical
History from the study
day 1 CRF; including
T2DM, hypothyroid, and
any other relevant Med
Hx to the SAE Med Hx
section, in a SAE safety
update
Feb-16-2021 14:46:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Safety update will be
submitted.
Feb-16-2021 14:43:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Safety update will be
submitted as soon as
information becomes
available.
Jan-15-2021 12:01:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL Please
submit a SAE safety
update for Prior Med Hx
for relevant conditions to
pancreas, such as
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895919
Page 161 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
endocrine conditions, GI
conditions, vascular
conditions.
Jan-15-2021 12:00:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical Please submit a
SAE safety update with
the method that
discovered the pancreatic
cyst, whether it was an
incidental finding or
symptomatic event,
reason for hospitalization
Jan-13-2021 15:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Pancreatic CystInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-13-2021 15:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/30/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-09-2021 21:49:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-09-2021 07:21:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New Information
Mar-09-2021 07:21:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/4/2021 UNK:UNKNew Information
Mar-09-2021 00:31:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical Event end date
is NONE, however
SAE report has end
date of 04Jan21. Please
review end date, and
submit end date to
SAE if applicable
Mar-04-2021 00:21:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895920
Page 162 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-03-2021 11:08:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject received a
COVID Vaccine
elsewhere. Per protocol
no longer eligible for
study.
Feb-25-2021 08:56:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition Follow-up
form is completed and
this Adverse Event is
still ongoing. Please
review and update as
appropriate.
Jan-13-2021 15:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-13-2021 15:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-05-2021 09:50:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-04-2021 08:45:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered SAE F/U has been
submitted.
Feb-24-2021 23:30:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Clinical - Followup; no
followup SAE has bee
received since
13Feb21; COVID test
status is Unknown (ie
NO test, or if YES test
then date & result).
Please submit a SAE
update with COVID
test information.
Feb-23-2021 12:47:44 ACV0PFEINFP6000 Query 2: Reissued:Candidate Clinical - Followup; no
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0895921
Page 163 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central Time
(US & Canada)followup SAE has bee
received since
13Feb21; COVID test
status is Unknown (ie
NO test, or if YES test
then date & result).
Please submit a SAE
update with COVID
test information.
Feb-12-2021 08:03:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered F/U form has been
submitted.
Jan-18-2021 04:03:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-15-2021 11:57:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical COVID test
status (yes/no) during
Hosp was not reported
in the SAE. Please
submit a follow-up
SAE form
[#2021026425] to
document if COVID
testing was performed
(YES/NO or info not
available) and if yes,
the date and results.
Jan-13-2021 15:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Pancreatic
Cyst: Response to "Is
the adverse event
serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Jan-13-2021 15:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated with c
ongenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolo
ng hospitalization?
YES
Did this serious event result in persistInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0895922
Page 164 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
ent or significant disability/incapacity
?
NO
Is this serious event life threatening?
NO
Other medically important serious eve
nt
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-13-2021 15:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-13-2021 15:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), thi
s event is due to:
OTHER
If Other, specify:
IDIOPATHICInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-13-2021 15:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-11-2021 02:48:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-10-2021 11:40:33 ACV0PFEINFP6000 auto query Query 1: Answered New Information
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895923
Page 165 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central Time
(US & Canada)(autoquery)
Mar-10-2021 11:40:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESNew Information
Mar-09-2021 09:41:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN:
Concomitant
medication and
non-drug therapy are
listed both as NO.
Please review and
update if applicable.
please ensure FU SAE
report is submitted if
new information is
shared.
Jan-13-2021 15:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-13-2021 15:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-10-2021 02:07:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-09-2021 07:20:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed Information
Mar-09-2021 07:20:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVED WITH SEQ
UELAEChanged Information
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0895924
Page 166 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Mar-09-2021
04:19:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Op
enedSAE
RECON:AER#2021026425,outcome
was reported as
RECOVERED/RESOLVED with
SEQUELAE to Safety DB however,
recorded as NOT
RECOVERED/NOT RESOLVED
on AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Jan-15-2021
14:50:53
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by Validation Check:
VC_AE001_35
Jan-15-2021
08:15:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredTranscription Error
Jan-15-2021
08:15:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NOT
RECO
VERE
D/NO
T RE
SOLV
EDTranscription Error
Jan-14-2021
19:41:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6841658;Response to "What
was the outcome of this adverse
event?" is 'Recovered/Resolved' or
'Recovered/Resolved with Sequelae'
but End Date/Time is missing.
Please review and update as
appropriate.
Jan-13-2021
15:59:40
(UTC-06:00)
Central TimeACV0PFEINFP6000 Data
Entry
:
RECOInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0895925
Page 167 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US &
Canada)VERE
D/RE
SOLV
ED
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-13-2021 15:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-18-2021 04:03:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2021026425Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895926
Page 168 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-04-2021 11:45:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895927
Page 169 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Mar-04-2021 11:45:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Mar-04-2021 11:45:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Mar-04-2021 11:45:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Mar-04-2021 11:45:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Moderna COVID-19 VaccineInitial Entry
5. Date:
Date Location User Value Reason
Mar-04-2021 11:45:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2021Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895928
Page 170 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021 08:49:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/22/2021Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895929
Page 171 of 174
***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, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-01-2021 10:33:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for Vaccin
ation 3
Participant is:
eligible per other protocol allowance(
s) and confirmed to have received onl
y placebo at Vaccination 1/2Transcription Error
Feb-25-2021 08:49:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willing to return for
Vaccination 3 OR otherwise not eligibleInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895930
Page 172 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-25-2021 08:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/22/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-01-2021
14:04:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Close
dResponse satisfies
query
Mar-01-2021
10:34:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answ
ereddata updated
Feb-26-2021
15:57:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: Open
edDMW7478456;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing to
return for Vaccination
3" is not selected in the
Further Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Feb-25-2021
08:51:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIG
IBILITY FOR
ADDITIONAL
VACCINATIO
NInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0895931
Page 173 of 174
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-12-2021 13:38:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged Information
Feb-25-2021 08:56:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Sep-30-2020 09:54:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-12-2020 14:54:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-12-2020 14:21:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-12-2021 13:38:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Feb/22/2021Changed Information
Feb-25-2021 08:56:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Feb/22/2021Initial Entry
Sep-30-2020 09:54:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/30/2020Initial Entry
Aug-12-2020 14:54:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/12/2020Initial Entry
Aug-12-2020 14:21:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/12/2020Initial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0895932
Page 174 of 174
***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, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191021 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-15-2020 15:27:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e2b\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0895933