125742 S1 M5 CRF c4591001 1251 12511145

Document text

Page 1 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832457
Page 2 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/10/2020
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832458
Page 3 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12511145]
2.Birth Date: /1961
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832459
Page 4 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832460
Page 5 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832461
Page 6 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832462
Page 7 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HYPERTENSION]
Start Date: UNK/UNK/1982
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[COPD]
Start Date: UNK/UNK/2001
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[EMPHYSEMA]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832463
Page 8 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: Jan/UNK/2019
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[STROKE]
Start Date: UNK/UNK/2002
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[DEPRESSION]
Start Date: UNK/UNK/2007
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ENLARGED PROSTATE]
Start Date: UNK/UNK/2012
Ongoing: YES
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832464
Page 9 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HYPOTHYROIDISM]
Start Date: UNK/UNK/2005
Ongoing: YES
1.iLine/MH Number: [ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ ]
Start Date: //
Ongoing:
1.jLine/MH Number: [ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ ]
Start Date: //
Ongoing:
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832465
Page 10 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
2.Weight: [157.0]
3.Unit: LB
4.Height: [68.0]
5.Unit: in
6.Body Mass Index: [23.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832466
Page 11 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/10/2020
2.Randomization Number: [256649]
3.Randomization Group: [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832467
Page 12 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
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 [BPYNMN]
5.bSample ID [BPYNMP]
5.cSample ID [BPYNMR]
5.dSample ID [BNWBLT]
5.eSample ID [BNWBLV]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832468
Page 13 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [BPYNM6]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832469
Page 14 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 10:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832470
Page 15 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832471
Page 16 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832472
Page 17 of 156
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832473
Page 18 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR90L4]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832474
Page 19 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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: Oct/1/2020 10:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832475
Page 20 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832476
Page 21 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/29/2020
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 [BR2K3M]
5.bSample ID [BR2K3N]
5.cSample ID [BR2K3P]
5.dSample ID [BSHYY3]
5.eSample ID [BSHYY4]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832477
Page 22 of 156
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832478
Page 23 of 156
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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: [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832479
Page 24 of 156
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832480
Page 25 of 156
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832481
Page 26 of 156
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832482
Page 27 of 156
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832483
Page 28 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832484
Page 29 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832485
Page 30 of 156
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832486
Page 31 of 156
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832487
Page 32 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/29/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832488
Page 33 of 156
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832489
Page 34 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832490
Page 35 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832491
Page 36 of 156
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still
ongoing?
6.Toxicity Grade:
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832492
Page 37 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.
9.Is this event related to study
treatment:
10.Latest Action Taken with
Study Treatment:
11.Was a Concomitant
Medication given?
12.Was a Non-Drug Treatment
given?
13.What was the outcome of
this adverse event?:
14.Did the adverse event cause
the subject to be
discontinued from the
study?
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832493
Page 38 of 156
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832494
Page 39 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832495
Page 40 of 156
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832496
Page 41 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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: //
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832497
Page 42 of 156
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832498
Page 43 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832499
Page 44 of 156
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832500
Page 45 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832501
Page 46 of 156
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832502
Page 47 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832503
Page 48 of 156
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832504
Page 49 of 156
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832505
Page 50 of 156
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832506
Page 51 of 156
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832507
Page 52 of 156
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832508
Page 53 of 156
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832509
Page 54 of 156
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832510
Page 55 of 156
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/9/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832511
Page 56 of 156
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832512
Page 57 of 156
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832513
Page 58 of 156
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832514
Page 59 of 156
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/24/2021
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832515
Page 60 of 156
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832516
Page 61 of 156
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/24/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832517
Page 62 of 156
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR4NXS]
5.bSample ID [BR4NXT]
5.cSample ID [BNVKLC]
5.dSample ID [BNVKLD]
5.eSample ID [BNVKLF]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832518
Page 63 of 156
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJ7K1]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832519
Page 64 of 156
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/24/2021 11:02
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832520
Page 65 of 156
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832521
Page 66 of 156
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832522
Page 67 of 156
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832523
Page 68 of 156
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832524
Page 69 of 156
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832525
Page 70 of 156
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832526
Page 71 of 156
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832527
Page 72 of 156
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832528
Page 73 of 156
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832529
Page 74 of 156
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832530
Page 75 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/29/2020
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832531
Page 76 of 156
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832532
Page 77 of 156
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Hayes
Williams Approved Mar-12-2021 10:49:16 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HayesWilliams, 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.
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832533
Page 78 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-11-2020 08:55:59 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832534
Page 79 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-24-2021 14:52:41 (UTC-06:00)
Central Time (US & Canada)NA
Not Applicable
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0832535
Page 80 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Hayes
Williams Approved Mar-12-2021 10:49:16 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HayesWilliams, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-12-2021 14:38:48 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-03-2020 09:35:24 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832536
Page 81 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832537
Page 82 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-11-2020
08:54:42
(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
Sep-11-2020
08:54:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832538
Page 83 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-11-2020
08:55:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consen
t Obtained
Sep/10/2020Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832539
Page 84 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-11-2020
08:54:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12511145Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-11-2020
08:48:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1961Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-11-2020
08:55:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832540
Page 85 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-11-2020
08:55:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-11-2020
08:55:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832541
Page 86 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-11-2020
08:55:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832542
Page 87 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-11-2020
08:56:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-11-2020
08:56:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-11-2020
08:56:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832543
Page 88 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Sep-11-2020
08:57:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical Hi
story Term:HYPERT
ENSION
Start Date: UNK/U
NK/1982
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-11-2020
08:57:02
(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
Sep-11-2020
08:57:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HYPERTENSIONInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832544
Page 89 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.a Start Date:
Date Location User Value Reason
Sep-11-2020
08:57:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1982Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-11-2020
08:57:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-11-2020
09:17:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:COPD
Start Date: UNK/U
NK/200
1
Ongoing: YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832545
Page 90 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Sep-11-2020
09:17:22
(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
Sep-11-2020
09:17:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COPDInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-11-2020
09:17:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2001Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-11-2020
09:17:22ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832546
Page 91 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00)
Central Time (US
& Canada)
1.c
Date Location User Value Reason
Sep-11-2020
09:17:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:EMPHY
SEMA
Start Date: UNK/U
NK/2016
Ongoing: YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832547
Page 92 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c Line/MH Number:
Date Location User Value Reason
Sep-11-2020
09:17:44
(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
Sep-11-2020
09:17:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EMPHYSEMAInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-11-2020
09:17:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-11-2020
09:17:44ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832548
Page 93 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00)
Central Time (US
& Canada)
1.d
Date Location User Value Reason
Sep-11-2020
09:18:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:4
Medical
History
Term:HYPERCH
OLESTER
OLEMIA
Start Da
te:Jan/UNK/2
019
Ongoing
:YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832549
Page 94 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d Line/MH Number:
Date Location User Value Reason
Sep-11-2020
09:18:15
(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
Sep-11-2020
09:18:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HYPERCHOLESTE
ROLEMIAInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-11-2020
09:18:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-11-2020
09:18:15ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832550
Page 95 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00)
Central Time (US
& Canada)
1.e
Date Location User Value Reason
Sep-11-2020
09:18:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:STROK
E
Start Date: UNK/U
NK/200
2
Ongoing: YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832551
Page 96 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e Line/MH Number:
Date Location User Value Reason
Sep-11-2020
09:18:34
(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
Sep-11-2020
09:18:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STROKEInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-11-2020
09:18:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-11-2020
09:18:34ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832552
Page 97 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00)
Central Time (US
& Canada)
1.f
Date Location User Value Reason
Sep-11-2020
09:18:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical His
tory Term:DEPRE
SSION
Start Date: UNK/U
NK/200
7
Ongoing: YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832553
Page 98 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.f Line/MH Number:
Date Location User Value Reason
Sep-11-2020
09:18:53
(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
Sep-11-2020
09:18:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DEPRESSIONInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-11-2020
09:18:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-11-2020
09:18:53ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832554
Page 99 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00)
Central Time (US
& Canada)
1.g
Date Location User Value Reason
Sep-11-2020
09:19:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical
History T
erm:ENLARG
ED PROS
TATE
Start Dat
e:UNK/UN
K/2012
Ongoing: YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832555
Page 100 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.g Line/MH Number:
Date Location User Value Reason
Sep-11-2020
09:19:21
(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
Sep-11-2020
09:19:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ENLARGED PROST
ATEInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-11-2020
09:19:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-11-2020
09:19:21ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832556
Page 101 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00)
Central Time (US
& Canada)
1.h
Date Location User Value Reason
Sep-11-2020
09:19:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical H
istory Ter
m:HYPOTH
YROIDIS
M
Start Date
:UNK/UN
K/2005
Ongoing: YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832557
Page 102 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.h Line/MH Number:
Date Location User Value Reason
Sep-11-2020
09:19:44
(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
Sep-11-2020
09:19:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HYPOTHYROIDISMInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-11-2020
09:19:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-11-2020
09:19:44ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832558
Page 103 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832559
Page 104 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-11-2020
08:57:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-11-2020
08:57:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
157.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-11-2020
08:57:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832560
Page 105 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-11-2020
08:57:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
68.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-11-2020
08:57:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-11-2020
08:57:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.9Initial Entry
7.a
Date Location User Value Reason
Sep-11-2020
08:57:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.4Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832561
Page 106 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-11-2020
08:57:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-11-2020
08:57:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.4Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-11-2020
08:57:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832562
Page 107 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.a Temperature Location:
Date Location User Value Reason
Sep-11-2020
08:57:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832563
Page 108 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-11-2020
08:58:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-11-2020
08:58:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
256649Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832564
Page 109 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020
08:58:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020
08:58:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020
08:59:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-11-2020
08:58:54
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832565
Page 110 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-11-2020
08:58:54
(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-11-2020
08:59:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPYNM
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020
08:59:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYNMNInitial Entry
5.b
Date Location User Value Reason
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832566
Page 111 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-11-2020
09:00:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPYNM
PInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-11-2020
09:00:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYNMPInitial Entry
5.c
Date Location User Value Reason
Sep-11-2020
09:00:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPYNM
RInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-11-2020
09:00:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYNMRInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832567
Page 112 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.d
Date Location User Value Reason
Sep-11-2020
09:03:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNWBL
TInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-11-2020
09:03:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWBLTInitial Entry
5.e
Date Location User Value Reason
Sep-11-2020
09:03:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BNWBL
VInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832568
Page 113 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.e Sample ID
Date Location User Value Reason
Sep-11-2020
09:03:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWBLVInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832569
Page 114 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020
09:04:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020
09:04:11
(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-12-2020
11:19:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-12-2020
02:50:10
(UTC-06:00)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832570
Page 115 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-11-2020
09:04:11
(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.
Sep-11-2020
09:04:11
(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-12-2020
11:19:31
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample
ID:BPYN
M6Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832571
Page 116 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-12-2020
11:19:31
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPYNM6Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832572
Page 117 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-11-2020
08:58:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020
08:58:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-11-2020
08:58:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832573
Page 118 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-11-2020
08:58:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020 10:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020
08:58:33
(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-11-2020
08:58:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-11-2020
08:58:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832574
Page 119 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-11-2020
08:58:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-11-2020
08:58:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832575
Page 120 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-11-2020
08:58:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832576
Page 121 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-01-2020
12:46:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832577
Page 122 of 156
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Oct-01-2020
12:46:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
2.a
Date Location User Value Reason
Oct-01-2020
12:46:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.7
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-01-2020
12:46:40
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832578
Page 123 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
& Canada)
2.a Temperature:
Date Location User Value Reason
Oct-01-2020
12:46:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-01-2020
12:46:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-01-2020
12:46:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832579
Page 124 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020
12:47:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020
12:47:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020
12:48:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-01-2020
12:47:01
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832580
Page 125 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-01-2020
12:47:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020
12:48:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR90L4Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-01-2020
12:48:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR90L4Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832581
Page 126 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-01-2020
12:47:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-01-2020
12:47:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-01-2020
12:47:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832582
Page 127 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-01-2020
12:47:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020 10:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-01-2020
12:47:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-01-2020
12:47:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-01-2020
12:47:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832583
Page 128 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-01-2020
12:47:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-01-2020
12:47:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832584
Page 129 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-29-2020
09:36:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2020Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832585
Page 130 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-29-2020
09:36:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020
09:36:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020
09:37:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-29-2020
09:36:54
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832586
Page 131 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-29-2020
09:36:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
Date Location User Value Reason
Oct-29-2020
09:37:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BR2K3
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-29-2020
09:37:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR2K3MInitial Entry
5.b
Date Location User Value Reason
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832587
Page 132 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-29-2020
09:37:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BR2K3
NInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-29-2020
09:37:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR2K3NInitial Entry
5.c
Date Location User Value Reason
Oct-29-2020
09:37:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR2K3PInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-29-2020
09:37:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR2K3PInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832588
Page 133 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.d
Date Location User Value Reason
Oct-29-2020
09:38:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BSHYY
3Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-29-2020
09:38:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSHYY3Initial Entry
5.e
Date Location User Value Reason
Oct-29-2020
09:38:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BSHYY
4Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832589
Page 134 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.e Sample ID
Date Location User Value Reason
Oct-29-2020
09:38:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSHYY4Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832590
Page 135 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-29-2020
09:39:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-29-2020
09:39:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-29-2020
09:39:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832591
Page 136 of 156
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021
14:50:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832592
Page 137 of 156
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-24-2021
14:50:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing t
o return for Vaccinatio
n 3
Participant is:
eligible per local/n
ational recommend
ations and confirm
ed to have received
only placebo at Vac
cination 1/2Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832593
Page 138 of 156
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-12-2021
14:38:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-02-2021
09:02:40
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-01-2021
14:27:50
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edOriginal value is
correct
Feb-23-2021
00:23:34
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Katherine
PuigQuery 1: Opened DM: Primary
Reason for
Unblinding is
"ASSESS
ELIGIBILITY
FOR
ADDITIONAL
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0832594
Page 139 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
VACCINATION",
but "Participant is
willing to return
for Vaccination 3"
is not selected in
the Further
Vaccination
Confirmation
CRF. Please
review and update
as appropriate.
Feb-12-2021
14:38:48
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGI
BILITY FOR A
DDITIONAL V
ACCINATIONInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0832595
Page 140 of 156
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021
14:51:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/24/2021Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832596
Page 141 of 156
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-24-2021
14:52:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consen
t Obtained
Feb/24/2021Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832597
Page 142 of 156
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-24-2021
14:53:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/24/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-24-2021
14:53:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Feb-24-2021
14:53:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832598
Page 143 of 156
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-24-2021
14:53:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-24-2021
14:53:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-24-2021
15:00:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-24-2021
14:53:24
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832599
Page 144 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-24-2021
14:53:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/24/2021Initial Entry
5.a
Date Location User Value Reason
Feb-24-2021
15:00:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BR4NX
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-24-2021
15:00:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR4NXSInitial Entry
5.b
Date Location User Value Reason
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832600
Page 145 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-24-2021
15:01:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BR4NX
TInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-24-2021
15:01:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR4NXTInitial Entry
5.c
Date Location User Value Reason
Feb-24-2021
15:02:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNVKL
CInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-24-2021
15:02:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNVKLCInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832601
Page 146 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.d
Date Location User Value Reason
Feb-24-2021
15:02:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNVKL
DInitial Entry
5.d Sample ID
Date Location User Value Reason
Feb-24-2021
15:02:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNVKLDInitial Entry
5.e
Date Location User Value Reason
Feb-24-2021
15:02:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNVKL
FInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832602
Page 147 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.e Sample ID
Date Location User Value Reason
Feb-24-2021
15:02:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNVKLFInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832603
Page 148 of 156
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-24-2021
15:02:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-24-2021
15:02:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-24-2021
15:03:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-24-2021
15:02:54
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832604
Page 149 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-24-2021
15:02:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/24/2021Initial Entry
5.a
Date Location User Value Reason
Feb-24-2021
15:03:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRJ7K1Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-24-2021
15:03:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRJ7K1Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832605
Page 150 of 156
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-24-2021
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-24-2021
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-24-2021
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832606
Page 151 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-24-2021
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/24/2021 11:02Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-24-2021
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-24-2021
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-24-2021
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832607
Page 152 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
8. Actual Dose:
Date Location User Value Reason
Feb-24-2021
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-24-2021
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-24-2021
15:03:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-24-2021
15:03:50ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832608
Page 153 of 156
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0832609
Page 154 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-29-2020
09:39:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-11-2020
08:58:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-11-2020
08:56:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-29-2020
09:39:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/29/2020Initial Entry
Sep-11-2020
08:58:01ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832610
Page 155 of 156
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00)
Central Time (US
& Canada)
Sep-11-2020
08:56:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832611
Page 156 of 156
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-03-2020
09:26:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3d02\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832612