125742 S1 M5 CRF c4591001 1133 11331317

Document text

Page 1 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804527
Page 2 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/28/2020
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804528
Page 3 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11331317]
2.Birth Date: 1975
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:
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804529
Page 4 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804530
Page 5 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804531
Page 6 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804532
Page 7 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[NEARSIGHTED]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[MYOPIA]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[RIGHT INGUINAL HERNIA]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804533
Page 8 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[SURGERY - RIGHT INGUINAL HERNIA REPAIR]
Start Date: Jan/UNK/2016
Ongoing: NO
End Date:
Jan/UNK/2016
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[SURGERY - VASECTOMY]
Start Date: Dec/UNK/2013
Ongoing: NO
End Date:
Dec/UNK/2013
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804534
Page 9 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [75.0]
3.Unit: kg
4.Height: [172.0]
5.Unit: cm
6.Body Mass Index: [25.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804535
Page 10 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [70859]
3.Randomization Group: [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804536
Page 11 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BP8BWS]
5.bSample ID [BP8BWT]
5.cSample ID [BP8BWV]
5.dSample ID [BPFSLF]
5.eSample ID [BPFSLG]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804537
Page 12 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BP8BW7]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804538
Page 13 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/28/2020 13:01
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
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804539
Page 14 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804540
Page 15 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804541
Page 16 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804542
Page 17 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
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 [BP8Y4P]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804543
Page 18 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/23/2020 12:13
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
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804544
Page 19 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804545
Page 20 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/28/2020
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 [BR9CR0]
5.bSample ID [BS82F6]
5.cSample ID [BS82F7]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804546
Page 21 of 127
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804547
Page 22 of 127
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804548
Page 23 of 127
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804549
Page 24 of 127
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804550
Page 25 of 127
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804551
Page 26 of 127
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804552
Page 27 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804553
Page 28 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804554
Page 29 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804555
Page 30 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804556
Page 31 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804557
Page 32 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804558
Page 33 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804559
Page 34 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804560
Page 35 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804561
Page 36 of 127
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804562
Page 37 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804563
Page 38 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804564
Page 39 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804565
Page 40 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804566
Page 41 of 127
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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).
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804567
Page 42 of 127
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804568
Page 43 of 127
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804569
Page 44 of 127
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804570
Page 45 of 127
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.[ ]      [ ]    Repeating
Pages
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804571
Page 46 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: //
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804572
Page 47 of 127
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804573
Page 48 of 127
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804574
Page 49 of 127
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804575
Page 50 of 127
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804576
Page 51 of 127
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804577
Page 52 of 127
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804578
Page 53 of 127
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804579
Page 54 of 127
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804580
Page 55 of 127
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804581
Page 56 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804582
Page 57 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804583
Page 58 of 127
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804584
Page 59 of 127
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804585
Page 60 of 127
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804586
Page 61 of 127
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804587
Page 62 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804588
Page 63 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804589
Page 64 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/17/2020
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804590
Page 65 of 127
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804591
Page 66 of 127
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804592
Page 67 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/28/2020
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804593
Page 68 of 127
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804594
Page 69 of 127
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804595
Page 70 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormAug-28-2020 14:34:44 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804596
Page 71 of 127
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-12-2021 14:26:57 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Howard
Schwartz Approved Nov-04-2020 15:11:36 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HowardSchwartz, 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.
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804597
Page 72 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-28-2020
14:30:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-28-2020
14:30:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804598
Page 73 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020
14:31:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/28/2020Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804599
Page 74 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020
14:30:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11331317Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020
14:30:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1975Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020
14:31:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804600
Page 75 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-28-2020
14:31:20
(UTC-05:00)
Eastern 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
Aug-28-2020
14:31:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804601
Page 76 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020
14:34:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804602
Page 77 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-28-2020
14:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020
14:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020
14:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804603
Page 78 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020
14:35:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:NEARSI
GHTED
Start Date: UNK/U
NK/200
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020
14:35:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
14:35:21
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
NEARSIGHTEDInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804604
Page 79 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-28-2020
14:35:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020
14:35:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-28-2020
14:35:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:MYOPI
A
Start Date: UNK/U
NK/2000
Ongoing: YESInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804605
Page 80 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020
14:35:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
14:35:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MYOPIAInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020
14:35:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020
14:35:37ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804606
Page 81 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.c
Date Location User Value Reason
Aug-28-2020
14:38:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:3
Medical
History
Term:RIGHT ING
UINAL HE
RNIA
Start Da
te:UNK/UNK/
2016
Ongoing
:NO
End Date:
UNK/UN
K/2016Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804607
Page 82 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.c Line/MH Number:
Date Location User Value Reason
Aug-28-2020
14:38:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
14:38:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHT INGUINAL
HERNIAInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-28-2020
14:38:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-28-2020
14:38:36ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804608
Page 83 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/2016
1.d
Date Location User Value Reason
Aug-28-2020
14:40:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/
MH N
umber
:4
Medic
al Hist
ory Te
rm:SURGERY - R
IGHT INGUIN
AL HERNIA
REPAIR
Start
Date:Jan/UNK/2016
Ongoi
ng:NO
End Date:
Jan/UNK/2
016Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804609
Page 84 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.d Line/MH Number:
Date Location User Value Reason
Aug-28-2020
14:40:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
14:40:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SURGERY - RIGHT
INGUINAL HERNIA
REPAIRInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-28-2020
14:40:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-28-2020
14:40:10ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804610
Page 85 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
Jan/UNK/2016
1.e
Date Location User Value Reason
Aug-28-2020
14:40:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:5
Medical
History
Term:SURGERY
- VASECTO
MY
Start Da
te:Dec/UNK/2
013
Ongoing
:NO
End Date:
Dec/UN
K/2013Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804611
Page 86 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.e Line/MH Number:
Date Location User Value Reason
Aug-28-2020
14:40:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
14:40:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SURGERY - VASEC
TOMYInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-28-2020
14:40:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/UNK/2013Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-28-2020
14:40:45ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804612
Page 87 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
Dec/UNK/2013
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804613
Page 88 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020
14:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020
14:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
75.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020
14:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804614
Page 89 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-28-2020
14:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
172.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020
14:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020
14:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25.4Initial Entry
7.a
Date Location User Value Reason
Aug-28-2020
14:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.2Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804615
Page 90 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020
14:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020
14:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020
14:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804616
Page 91 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020
14:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804617
Page 92 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020
14:42:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020
14:42:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
70859Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804618
Page 93 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020
14:42:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020
14:42:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
16:39:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-28-2020
14:42:58
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804619
Page 94 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-28-2020
14:42:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020
16:39:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP8BW
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
16:39:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8BWSInitial Entry
5.b
Date Location User Value Reason
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804620
Page 95 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-28-2020
16:40:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP8BW
TInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020
16:40:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8BWTInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020
16:40:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP8BW
VInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-28-2020
16:40:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8BWVInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804621
Page 96 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.d
Date Location User Value Reason
Aug-28-2020
17:19:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPFSLFInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-28-2020
17:19:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPFSLFInitial Entry
5.e
Date Location User Value Reason
Aug-28-2020
17:19:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPFSL
GInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804622
Page 97 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.e Sample ID
Date Location User Value Reason
Aug-28-2020
17:19:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPFSLGInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804623
Page 98 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020
14:43:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020
14:43:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
16:54:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-28-2020
14:43:05
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804624
Page 99 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-28-2020
14:43:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020
16:54:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP8BW
7Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
16:54:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8BW7Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804625
Page 100 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020
14:43:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020
14:43:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020
14:43:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804626
Page 101 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-28-2020
14:43:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020 13:01Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020
14:43:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020
14:43:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-28-2020
14:43:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804627
Page 102 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-28-2020
14:43:40
(UTC-05:00)
Eastern 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
Aug-28-2020
14:43:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804628
Page 103 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-28-2020
14:43:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804629
Page 104 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020
01:48:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed As per site
confirmation -
updated PD
tracker
Oct-14-2020
16:52:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered A protocol
deviation was
performed.
Subject came
out of window
due to work.
Sep-24-2020
06:15:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened PDQ: DOV at
this visit is out
of window (3
day) from
DOV (28/Aug
/2020) at
V1D1VX1L.
Please either
update DOV or
confirm
whether visit is
out of window
due to
temporary
delay of
vaccination/
else provide
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804630
Page 105 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
details as
appropriate.
Sep-23-2020
13:38:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804631
Page 106 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020
13:45:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-23-2020
13:45:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.2
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-23-2020
13:45:00
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804632
Page 107 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-23-2020
13:45:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-23-2020
13:45:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-23-2020
13:45:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804633
Page 108 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020
13:45:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020
13:45:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020
10:26:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-24-2020
05:37:31
(UTC-05:00)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804634
Page 109 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-23-2020
13:45:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-23-2020
13:45:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020
10:26:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP8Y4
PInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804635
Page 110 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-24-2020
10:26:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8Y4PInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804636
Page 111 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-23-2020
13:46:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020
13:46:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020
13:46:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804637
Page 112 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-23-2020
13:46:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020 12:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020
13:46:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-23-2020
13:46:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-23-2020
13:46:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804638
Page 113 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-23-2020
13:46:34
(UTC-05:00)
Eastern 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-23-2020
13:46:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804639
Page 114 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-28-2020
13:21:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/28/2020Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804640
Page 115 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020
13:21:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020
13:21:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020
08:37:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-29-2020
07:28:47
(UTC-05:00)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804641
Page 116 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-28-2020
13:21:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-28-2020
13:21:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Oct/28/2020Initial Entry
5.a
Date Location User Value Reason
Oct-29-2020
08:37:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BR9CR
0Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804642
Page 117 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-29-2020
08:37:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR9CR0Initial Entry
5.b
Date Location User Value Reason
Oct-29-2020
09:06:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS82F6Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-29-2020
09:06:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS82F6Initial Entry
5.c
Date Location User Value Reason
Oct-29-2020
09:27:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BS82F
7Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804643
Page 118 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.c Sample ID
Date Location User Value Reason
Oct-29-2020
09:27:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS82F7Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804644
Page 119 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-02-2020
16:31:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-02-2020
14:45:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answer
edData has been
corrected
Nov-02-2020
14:45:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/28/2020Data has been
corrected
Nov-02-2020
12:05:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 1: Opened As per CRF
guidelines, the
treatment
period is
defined as 1st
vaccination
visit through
the 1-month
post
vaccination
visit after the
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804645
Page 120 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2nd
vaccination.
Please
complete
treatment
disposition
CRF and
update date of
EOT to match
the date the
Visit 3.
Sep-23-2020
13:49:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-23-2020
13:49:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-23-2020
13:49:49
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804646
Page 121 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time (US
& Canada)
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804647
Page 122 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-12-2021
14:27:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804648
Page 123 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-12-2021
14:27:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing t
o return for Vaccinatio
n 3
Participant is:
eligible and NOT c
onfirmed to have r
eceived only place
bo at Vaccination 1
/2Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804649
Page 124 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-12-2021
14:26:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-12-2021
14:26:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0804650
Page 125 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject Status
Date Location User Value Reason
Sep-23-2020
13:49:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-28-2020
14:42:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-28-2020
14:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-02-2020
14:45:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/28/2020Data has been
corrected
Sep-23-2020
13:49:49ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/23/2020Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804651
Page 126 of 127
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
Aug-28-2020
14:42:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
Aug-28-2020
14:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804652
Page 127 of 127
***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, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020
08:26:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3ef3\Final\Final On: 01-Apr-2021 05:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804653