125742 S1 M5 CRF c4591001 1127 11271112

Document text

Page 1 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981741
Page 2 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/20/2020
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981742
Page 3 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Demography
1.Subject ID [11271112]
2.Birth Date: /1967
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): AMERICAN INDIAN OR ALASKA NATIVE
WHITE
6.Racial Designation:
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981743
Page 4 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/20/2020
2.Erroneous Visit
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981744
Page 5 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981745
Page 6 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981746
Page 7 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to Tramadol]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to Chlor-Trimeton]
Start Date: UNK/UNK/1978
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurrent seasonal allergies]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tinnitus]
Start Date: UNK/UNK/1992
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myopia]
Start Date: UNK/UNK/2008
Ongoing: YES
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981747
Page 8 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic obstructive pulmonary disease]
Start Date: UNK/UNK/1990
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypoglycemia]
Start Date: UNK/UNK/1985
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myocardial Infarction stress related]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981748
Page 9 of 129
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
2.Weight: [71.8]
3.Unit: kg
4.Height: [168.0]
5.Unit: cm
6.Body Mass Index: [25.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981749
Page 10 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/20/2020
2.Randomization Number: [58862]
3.Randomization Group: [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981750
Page 11 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[only could obtain 1 retain not 2]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3S0N]
5.bSample ID [BP3S0P]
5.cSample ID [BP3S0R]
5.dSample ID [BPL353]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981751
Page 12 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
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 [BP3S0L]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981752
Page 13 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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/20/2020 18:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981753
Page 14 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981754
Page 15 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981755
Page 16 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981756
Page 17 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BP3S34]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981757
Page 18 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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/10/2020 14:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981758
Page 19 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981759
Page 20 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/9/2020
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 [BP9VMJ]
5.bSample ID [BPL4G8]
5.cSample ID [BPL4G9]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981760
Page 21 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981761
Page 22 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981762
Page 23 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981763
Page 24 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981764
Page 25 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981765
Page 26 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981766
Page 27 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981767
Page 28 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981768
Page 29 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981769
Page 30 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981770
Page 31 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981771
Page 32 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981772
Page 33 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981773
Page 34 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981774
Page 35 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981775
Page 36 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Unplanned Assessments
1.Assessments
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981776
Page 37 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/9/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981777
Page 38 of 129
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Dec/4/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981778
Page 39 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981779
Page 40 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981780
Page 41 of 129
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1  Cardiopulmonary arr
est Dec/4/2020 22:
00 NO
End Date Time:
Dec/4/2020 UNK:UNK
 Repeating
Pages
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981781
Page 42 of 129
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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)[Cardiopulmonary arrest]
4.Start Date Time: Dec/4/2020 22:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/4/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
NO
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:
[underlying cardiac disease]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981782
Page 43 of 129
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2020481968]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981783
Page 44 of 129
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
 1.          Repeating
Pages
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981784
Page 45 of 129
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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[ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981785
Page 46 of 129
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981786
Page 47 of 129
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981787
Page 48 of 129
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981788
Page 49 of 129
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981789
Page 50 of 129
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981790
Page 51 of 129
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981791
Page 52 of 129
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981792
Page 53 of 129
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981793
Page 54 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981794
Page 55 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981795
Page 56 of 129
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981796
Page 57 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981797
Page 58 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981798
Page 59 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981799
Page 60 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981800
Page 61 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981801
Page 62 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981802
Page 63 of 129
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981803
Page 64 of 129
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981804
Page 65 of 129
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981805
Page 66 of 129
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981806
Page 67 of 129
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Dec/4/2020
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Cardiopulmonary arrest]
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981807
Page 68 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Dec/4/2020
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981808
Page 69 of 129
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981809
Page 70 of 129
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Tracy Klein  Approved Jan-21-2021 12:03:41 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TracyKlein, 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.
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981810
Page 71 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormAug-21-2020 09:00:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981811
Page 72 of 129
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Tracy Klein  Approved Jan-21-2021 12:03:41 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TracyKlein, 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 Dec-05-2020 14:18:59 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tracy Klein  Approved Oct-22-2020 13:18:51 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TracyKlein, 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.
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981812
Page 73 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-21-2020 08:56:59
(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-21-2020 08:56:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981813
Page 74 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-21-2020 08:58:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/20/2020Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981814
Page 75 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-21-2020 08:56:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11271112Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-21-2020 08:56:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1967Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-21-2020 09:00:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-21-2020 09:00:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-21-2020 09:00:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AMERICAN INDIAN OR ALA
SKA NATIVE
WHITEInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981815
Page 76 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-21-2020 09:00:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981816
Page 77 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-21-2020 09:01:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-21-2020 09:01:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-21-2020 09:01:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981817
Page 78 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Aug-21-2020 09:02:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Allergy to Tram
adol
Start Date: UNK/UNK/201
5
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-21-2020 09:02:35
(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-21-2020 09:02:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Allergy to TramadolInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-21-2020 09:02:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-21-2020 09:02:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981818
Page 79 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-21-2020 09:02:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Allergy to Chlor-T
rimeton
Start Date: UNK/UNK/1978
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-21-2020 09:02:56
(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-21-2020 09:02:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Allergy to Chlor-TrimetonInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-21-2020 09:02:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1978Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-21-2020 09:02:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-21-2020 09:03:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981819
Page 80 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical Histor
y Term:Recurrent seasonal
allergies
Start Date: UNK/UNK/2018
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-21-2020 09:03:53
(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-21-2020 09:03:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 
)Data Entry:
Recurrent seasonal allergiesInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-21-2020 09:03:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-21-2020 09:03:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-21-2020 09:04:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:Tinnitus
Start Date: UNK/UNK/19
92
Ongoing: YESInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981820
Page 81 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.d Line/MH Number:
Date Location User Value Reason
Aug-21-2020 09:04:09
(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-21-2020 09:04:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TinnitusInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-21-2020 09:04:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1992Initial Entry
1 d Ongoing
Date Location User Value Reason
Aug-21-2020 09:04:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-21-2020 09:04:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:Myopia
Start Date: UNK/UNK/20
08
Ongoing: YESInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981821
Page 82 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.e Line/MH Number:
Date Location User Value Reason
Aug-21-2020 09:04:25
(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-21-2020 09:04:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MyopiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-21-2020 09:04:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1 e Ongoing
Date Location User Value Reason
Aug-21-2020 09:04:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-21-2020 09:05:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:Chronic obstructive p
ulmonary disease
Start Date: UNK/UNK/1990
Ongoing: YESInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981822
Page 83 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.f Line/MH Number:
Date Location User Value Reason
Aug-21-2020 09:05:03
(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-21-2020 09:05:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Chronic obstructive pulmonary di
seaseInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-21-2020 09:05:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.f Ongoing
Date Location User Value Reason
Aug-21-2020 09:05:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-21-2020 09:05:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Te
rm:Hypoglycemia
Start Date: UNK/UNK/19
85
Ongoing: YESInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981823
Page 84 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.g Line/MH Number:
Date Location User Value Reason
Aug-21-2020 09:05:28
(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
Dec-14-2020 21:07:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Closed Response satisfies
query
Dec-14-2020 12:08:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered medical history
updated
Dec-11-2020 16:35:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Opened Per one of the
answers to a
CLINIQUERY,
"Subject has a
history of MI stress
related with a start
date of 2008." This
information is
missing in the MHx,
kindly reassess and
update form for
additional medical
history. Thank you.
Aug-21-2020 09:05:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypoglycemiaInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-21-2020 09:05:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1985Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-21-2020 09:05:28 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0981824
Page 85 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-06:00) Central
Time (US & Canada)YES
1.h
Date Location User Value Reason
Dec-14-2020 12:09:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH N
umber:8
Medical His
tory Term:Myocardial Infarcti
on stress related
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008Initial Entry
Dec-14-2020 12:08:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:Myocardial Infarcti
on stress related
Start Date:
Ongoing:New Information
Dec-14-2020 12:07:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:8
Medical History T
erm:MI stress rela
ted
Start Date:
Ongoing:Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981825
Page 86 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.h Line/MH Number:
Date Location User Value Reason
Dec-14-2020 12:07:05
(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
Dec-14-2020 12:08:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Myocardial Infarction stress relate
dNew Information
Dec-14-2020 12:07:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MI stress relatedInitial Entry
1.h Start Date:
Date Location User Value Reason
Dec-14-2020 12:09:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.h Ongoing:
Date Location User Value Reason
Dec-14-2020 12:09:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981826
Page 87 of 129
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Aug-21-2020 09:08:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-21-2020 09:08:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
71.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-21-2020 09:08:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-21-2020 09:08:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
168.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-21-2020 09:08:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-21-2020 09:08:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25.4Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981827
Page 88 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7.a
Date Location User Value Reason
Aug-21-2020 09:08:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 37.2
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-21-2020 09:08:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-21-2020 09:08:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
37.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-21-2020 09:08:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-21-2020 09:08:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981828
Page 89 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-21-2020 09:09:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-21-2020 09:09:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
58862Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981829
Page 90 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 09:27:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 09:27:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 09:27:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-21-2020 09:27:11
(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-21-2020 09:27:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Aug-21-2020 09:28:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
only could obtain 1 retain not 2Initial Entry
5.a
Date Location User Value Reason
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981830
Page 91 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-21-2020 09:27:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3S0NInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020 09:27:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3S0NInitial Entry
5.b
Date Location User Value Reason
Aug-21-2020 09:27:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3S0PInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-21-2020 09:27:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3S0PInitial Entry
5.c
Date Location User Value Reason
Aug-21-2020 09:27:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3S0RInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-21-2020 09:27:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3S0RInitial Entry
5.d
Date Location User Value Reason
Aug-21-2020 09:28:01
(UTC-06:00) Central TimeACV0PFEINFP6000  Data Entry:
Sample ID: BPL353Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981831
Page 92 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(US & Canada)
5.d Sample ID
Date Location User Value Reason
Aug-21-2020 09:28:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPL353Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981832
Page 93 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 09:28:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 09:28:44
(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-21-2020 09:29:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-21-2020 09:28:44
(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-21-2020 09:28:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020 09:29:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3S0LInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981833
Page 94 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-21-2020 09:29:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3S0LInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981834
Page 95 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-21-2020 09:09:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-21-2020 09:09:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-21-2020 09:09:44
(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 09:09:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020 18:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-21-2020 09:09:44
(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-21-2020 09:09:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981835
Page 96 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7. Route:
Date Location User Value Reason
Aug-21-2020 09:09:44
(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-21-2020 09:09:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-21-2020 09:09:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981836
Page 97 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-10-2020 17:10:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-10-2020 16:27:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-10-2020 16:27:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTTranscription Error
Sep-02-2020 09:53:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Subject not in
reactogenecity
eDiary per TrialMax
Aug-21-2020 09:10:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-
DIARY COLLECTED FOR TH
IS SUBJECTInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981837
Page 98 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-10-2020 16:27:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981838
Page 99 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020 16:28:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2.a
Date Location User Value Reason
Sep-10-2020 16:28:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 37.0
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-10-2020 16:28:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-10-2020 16:28:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-10-2020 16:28:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981839
Page 100 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Sep-10-2020 16:28:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981840
Page 101 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 16:23:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 16:23:24
(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-10-2020 16:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-10-2020 16:23:24
(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-10-2020 16:23:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020 16:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3S34Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981841
Page 102 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Sep-10-2020 16:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP3S34Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981842
Page 103 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-10-2020 16:28:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020 16:28:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020 16:28:39
(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-10-2020 16:28:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020 14:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020 16:28:39
(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-10-2020 16:28:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981843
Page 104 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7. Route:
Date Location User Value Reason
Sep-10-2020 16:28:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020 16:28:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-10-2020 16:28:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981844
Page 105 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-09-2020 15:35:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981845
Page 106 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-09-2020 16:59:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-09-2020 16:59:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-09-2020 16:59:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-09-2020 16:59:06
(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.
Oct-09-2020 16:59:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/9/2020Initial Entry
5.a
Date Location User Value Reason
Oct-09-2020 16:59:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9VMJInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981846
Page 107 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Oct-09-2020 16:59:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9VMJInitial Entry
5.b
Date Location User Value Reason
Oct-09-2020 17:01:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPL4G8Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-09-2020 17:01:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPL4G8Initial Entry
5.c
Date Location User Value Reason
Oct-09-2020 17:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPL4G9Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-09-2020 17:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPL4G9Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981847
Page 108 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-09-2020 15:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020 15:36:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020 15:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981848
Page 109 of 129
***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, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-14-2020 12:09:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-14-2020 12:09:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Dec-14-2020 12:09:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DEATHInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981849
Page 110 of 129
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Date Location User Value Reason
Dec-05-2020 14:18:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981850
Page 111 of 129
***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, Frozen, Not Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Category:
Date Location User Value Reason
Dec-05-2020 14:18:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-05-2020 14:18:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Feb-24-2021
14:59:50
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Giselle Castillo Query
4: Clo
sedOk, thanks
Feb-17-2021
16:16:55
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Ans
weredaccording to corner's
office told mother could
take 120-130 days from
when subject passed on
12/4/2020
Feb-17-2021
10:58:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Giselle Castillo Query
4: Op
enedMedical Monitor_ Per
report, "An autopsy was
performed, and results
were not provided".
Could you pls provide
any updates about the
results? thanks
Jan-17-2021
04:47:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Clo
sedResponse satisfies query
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0981851
Page 112 of 129
***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, Frozen, Not Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Jan-13-2021
11:15:38
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Ans
weredSerious adverse event
form faxed 13Jan2021
Jan-08-2021
06:29:42
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Op
enedSAE RECON:
AER#2020362930,the
term was reported as
'Cardiopulmonary arrest
related to myocardial
infarction' in Safety
database while recorded
as 'Cardiopulmonary
arrest' in AE CRF. If
safety update is required
please submit a
follow-up form.
Jan-05-2021
17:28:15
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
2: Clo
sedDiscrepancy has been
closed.
Jan-05-2021
15:03:18
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
2: Ans
weredChanged Information
Jan-05-2021
15:03:18
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Cardi
opulm
onary
arrestChanged Information
Jan-05-2021
07:10:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Rei
ssued:
Opene
dThank you for
confirming; however,
coding cannot take place
with the term as is.
Please split the term into
CARDIOPULMONARY
ARREST and
MYOCARDIAL
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0981852
Page 113 of 129
***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, Frozen, Not Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
INFARCTION and
submit separately. Thank
you.
Dec-21-2020
03:58:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Dec-18-2020
14:57:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ans
weredConfirm term is correct
this was determined by
PI after conversation
with medical monitor
term will not be
separated.
Dec-18-2020
14:42:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
2: Op
enedMultiple concepts in the
term
CARDIOPULMONARY
ARREST RELATED TO
MYOCARDIAL
INFARCTION. Split the
term into
CARDIOPULMONARY
ARREST and
MYOCARDIAL
INFARCTION and
submit separately. Thank
you.
Dec-18-2020
09:46:59
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Cardi
opulm
onary
arrest
relate
d to m
yocar
dial in
farctio
nTranscription Error
Dec-18-2020
09:46:36
(UTC-06:00)
Central TimeACV0PFEINFP6000  auto query (autoquery) Query
1: Ans
weredNew Information
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0981853
Page 114 of 129
***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, Frozen, Not Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(US &
Canada)
Dec-18-2020
09:46:36
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Cardi
opath
y arre
st rela
ted to
myoc
ardial
infarct
ionNew Information
Dec-11-2020
04:07:18
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM1: Per response
'cause correctly
unknown waiting
autopsy results' kindly
update the data once
available, then change
the query status to
answered. Thank you.
Dec-09-2020
09:56:47
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredcause correctly unknown
waiting autopsy results
Dec-06-2020
08:34:47
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW6347781;This
'Adverse Event' contains
the term DEATH. If
known, please provide
the cause of death as the
AE term with an
outcome of FATAL or
clarify.
Dec-05-2020
14:18:59
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Death
unkno
wn ca
useInitial Entry
4. Start Date Time:
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0981854
Page 115 of 129
***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, Frozen, Not Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Dec-05-2020 14:18:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/4/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-05-2020 14:18:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/4/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-05-2020 14:31:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
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
Dec-22-2020 05:37:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Dec-18-2020 09:46:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate For AE
Cardiopulmonary
arrest related to
myocardial infarction:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Dec-18-2020 09:46:36
(UTC-06:00) CentralACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate For AE Cardiopathy
arrest related to
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981855
Page 116 of 129
***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, Frozen, Not Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada) myocardial infarction:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Dec-11-2020 01:06:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-09-2020 10:00:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Serious Adverse
Event Number: For
Pfizer Use Only site
does not enter this
information
Dec-07-2020 06:53:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened For AE Death
unknown cause:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Dec-05-2020 14:18:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Death
unknown cause:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Dec-05-2020 14:18:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birth
defect?
NO
Did this serious event result in d
eath?
YES
Did this serious event require orInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981856
Page 117 of 129
***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, Frozen, Not Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
prolong hospitalization?
NO
Did this serious event result in p
ersistent or significant disability
/incapacity?
NO
Is this serious event life threaten
ing?
NO
Other medically important serio
us event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-05-2020 14:18:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-10-2020 18:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-09-2020 09:59:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject has a history
of MI stress related
with a start date of
2008.
Dec-07-2020 18:27:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Death
unknown cause:
Question 9 states this
is related to a
underlying cardiac
disease. Is this a
reportable medhx? If
so, update the medhx
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0981857
Page 118 of 129
***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, Frozen, Not Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
as appropriate.
Thanks
Dec-05-2020 14:31:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
underlying cardiac diseaseInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-05-2020 14:31:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-05-2020 14:18:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-05-2020 14:18:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-14-2020
23:08:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Cl
osedResponse satisfies
query
Dec-14-2020
12:10:53
(UTC-06:00)ACV0PFEINFP6000  Query 2: A
nsweredFU disposition page
completed
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (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-2021-5683-0981858
Page 119 of 129
***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, Frozen, Not Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Central Time
(US & Canada)
Dec-10-2020
22:58:50
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: R
eissued:Op
enedDisposition form at
follow up visit is
still blank. Please
complete. And
consider entering
DEATH as 'Status',
Or clarify.
Dec-09-2020
09:55:40
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: A
nsweredpage completed
Dec-07-2020
02:45:31
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 2: O
penedDMW6347780;The
outcome of this AE
is selected as
FATAL, but there
are no Disposition
eCRFs with a
'Status' of DEATH.
Please review and
update as
appropriate.
Dec-05-2020
14:35:01
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Cl
osedClose Auto Query
Dec-05-2020
14:18:59
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: O
penedResponse to "What
was the outcome of
this adverse event?"
is 'Fatal' but Date of
Collection /
Notification of
Death on the Death
Details form is not
completed. Please
review and update
as appropriate.
Dec-05-2020
14:18:59
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
FATALInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0981859
Page 120 of 129
***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, Frozen, Not Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-05-2020 14:18:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981860
Page 121 of 129
***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, Frozen, Not Complete
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-22-2020 05:37:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020481968Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981861
Page 122 of 129
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Dec-05-2020 14:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/4/2020Initial Entry
2.a
Date Location User Value Reason
Jan-05-2021 15:03:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cause of Dea
th Status:PRIMARY CAUS
E OF DEATH
Cause of Dea
th:Cardiopulmonary
arrestChanged Information
Dec-18-2020 09:47:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cause of
Death Sta
tus:PRIMARY CAUSE O
F DEATH
Cause of
Death:Cardiopulmonary arre
st related to myocardia
l infarctionNew Information
Dec-14-2020 12:05:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cause of De
ath Status:
Cause of De
ath:death cause unknow
n pending autopsyChanged Information
Dec-05-2020 14:36:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cause of Dea
th Status:
Cause of Dea
th:cause unknown pe
nding autopsyTranscription Error
Dec-05-2020 14:35:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cause of Dea
th Status:PRIMARY CAUS
E OF DEATH
Cause of Dea
th:cause unknown pe
nding autopsyInitial Entry
Dec-05-2020 14:35:46
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Cause of DeaInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0981862
Page 123 of 129
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada) th Status:
Cause of Dea
th:cause unknown pe
nding autopsy
2.a Cause of Death Status:
Date Location User Value Reason
Dec-21-2020 02:09:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Closed as data
updated.
Dec-18-2020 09:47:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Dec-18-2020 09:47:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CAUSE OF DEATHNew Information
Dec-11-2020 02:26:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Please confirm when
data will be available
for data entry?
Dec-09-2020 10:02:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Pending since this is
unknown at this time.
Dec-07-2020 01:13:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Please complete
this item. Thank you.
Dec-05-2020 14:36:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-05-2020 14:35:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CAUSE OF DEATHInitial Entry
2.a Cause of Death:
Date Location User ValueReason
Jan-05-2021
17:27:48
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
4: Clo
sedDiscrepancy has been
closed.
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (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) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0981863
Page 124 of 129
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Jan-05-2021
15:03:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
4: Ans
weredChanged Information
Jan-05-2021
15:03:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Cardi
opulm
onary
arrestChanged Information
Jan-05-2021
07:09:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Rei
ssued:
Opene
dThank you for
confirming; however,
coding cannot take place
with multiple terms
entered. Please update
the cause of death with
only the primary
underlying cause.
Dec-18-2020
14:57:45
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Ans
weredConfirm term is correct
this was determined by
PI after conversation
with medical monitor
term will not be
separated.
Dec-18-2020
14:42:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
4: Op
enedMultiple concepts in the
term
CARDIOPULMONARY
ARREST RELATED TO
MYOCARDIAL
INFARCTION. Split the
term into
CARDIOPULMONARY
ARREST and
MYOCARDIAL
INFARCTION and
submit separately. Thank
you.
Dec-18-2020
09:47:50
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000  Data
Entry
:
Cardi
opulmNew Information
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0981864
Page 125 of 129
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Canada) onary
arrest
relate
d to m
yocar
dial in
farctio
n
Dec-14-2020
13:21:50
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
3: Clo
sedDiscrepancy has been
closed.
Dec-14-2020
12:05:05
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
3: Ans
weredChanged Information
Dec-14-2020
12:05:05
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
death
cause
unkno
wn pe
nding
autops
yChanged Information
Dec-12-2020
08:03:13
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
3: Op
enedClarify CAUSE
UNKNOWN PENDING
AUTOPSY as
follows...Term appears
incomplete. If reporting
DEATH CAUSE
UNKNOWN PENDING
AUTOPSY, update the
verbatim term as such.
Otherwise clarify further
and update the term as
appropriate. Thank you.
Dec-12-2020
07:59:06
(UTC-06:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
2: Clo
sedDiscrepancy has been
closed.
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0981865
Page 126 of 129
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Central Time
(US &
Canada)
Dec-11-2020
16:58:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
2: Op
enedClarify CAUSE
UNKNOWN PENDING
AUTOPSY as
follows...Term appears
incomplete. If reporting
DEATH CAUSE
UNKNOWN PENDING
AUTOPSY, update the
verbatim term as such.
Otherwise clarify further
and update the term as
appropriate. Thank you.
Dec-11-2020
13:01:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
1: Clo
sedDiscrepancy has been
closed.
Dec-09-2020
10:02:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredsite does not have
additional information
regarding cause of death
at this time. Information
will be completed once
information is obtained
Dec-06-2020
11:21:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
1: Op
enedClarify CAUSE
UNKNOWN PENDING
AUTOPSY as
follows...Term appears
incomplete. If reporting
DEATH CAUSE
UNKNOWN PENDING
AUTOPSY, update the
verbatim term as such.
Otherwise clarify further
and update the term as
appropriate. Thank you.
Dec-05-2020
14:35:46
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
cause
unkno
wn peInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0981866
Page 127 of 129
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
nding
autops
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090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981867
Page 128 of 129
***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: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-14-2020 12:09:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-09-2020 15:36:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-21-2020 09:09:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-21-2020 09:01:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-14-2020 12:09:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/4/2020Initial Entry
Oct-09-2020 15:36:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/9/2020Initial Entry
Aug-21-2020 09:09:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
Aug-21-2020 09:01:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981868
Page 129 of 129
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1127 Site Name: (1127) Heartland Research Associates
Subject No: 11271112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020 08:42:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae303c\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981869