Document text
Page 1 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804351
Page 2 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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/19/2020
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804352
Page 3 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11331207]
2.Birth Date: /1999
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804353
Page 4 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804354
Page 5 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804355
Page 6 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804356
Page 7 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804357
Page 8 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
2.Weight: [68.9]
3.Unit: kg
4.Height: [159.0]
5.Unit: cm
6.Body Mass Index: [27.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804358
Page 9 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/19/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804359
Page 10 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/19/2020
2.Randomization Number: [56917]
3.Randomization Group: [ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804360
Page 11 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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/19/2020
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 [BPY1RD]
5.bSample ID [BPY1RF]
5.cSample ID [BPY1RG]
5.dSample ID [BPFSD9]
5.eSample ID [BPFSDB]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804361
Page 12 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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/19/2020
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 [BPY1PK]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804362
Page 13 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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/19/2020 16:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804363
Page 14 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804364
Page 15 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Applicable
//Comments
2.Erroneous Visit Not Applicable Comments
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804365
Page 16 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Temperature: Not Applicable
[ ]Comments
Unit: Not Applicable Comments
Temperature Location: Not Applicable Comments
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804366
Page 17 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804367
Page 18 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804368
Page 19 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Applicable Comments
2.Treatment Name Not Applicable
[ ]Comments
3.Formulation: Not Applicable Comments
4.Dose Date Time: Not Applicable
//Comments
5.Anatomical Location: Not Applicable Comments
6.Body Side: Not Applicable Comments
7.Route: Not Applicable Comments
8.Actual Dose: Not Applicable
[ ]Comments
9.Unit: Not Applicable Comments
10.Timeframe Subject Was Observed Not Applicable Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Applicable Comments
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804369
Page 20 of 176
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804370
Page 21 of 176
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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 [ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804371
Page 22 of 176
***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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804372
Page 23 of 176
***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: 11331207 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 [ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804373
Page 24 of 176
***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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804374
Page 25 of 176
***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: 11331207 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 [ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804375
Page 26 of 176
***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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804376
Page 27 of 176
***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: 11331207 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 [ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804377
Page 28 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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:
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804378
Page 29 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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: [ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804379
Page 30 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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 [ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804380
Page 31 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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 [ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804381
Page 32 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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?
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804382
Page 33 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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:
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804383
Page 34 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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:
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804384
Page 35 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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 [ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804385
Page 36 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804386
Page 37 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804387
Page 38 of 176
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/30/2020
2.Phase of Disposition: VACCINATION
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [SUBJECT WITHDREW CONSENT]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804388
Page 39 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Sep/30/2020 Comments
2.Phase of Disposition: FOLLOW-UP Comments
3.Status: WITHDRAWAL BY SUBJECT Comments
4.Specify Status: [Subject withdrew consent] Comments
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804389
Page 40 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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:
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804390
Page 41 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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 [ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804391
Page 42 of 176
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 Exposure During Pregn
acy Aug/19/2020 16:
52 NO
End Date Time:
Sep/26/2020 UNK:UNK
Repeating
Pages
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804392
Page 43 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Exposure During Pregnacy]
4.Start Date Time: Aug/19/2020 16:52
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/26/2020 UNK:UNK
6.Toxicity Grade: Not Applicable Comments
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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Pregnacy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804393
Page 44 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804394
Page 45 of 176
***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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804395
Page 46 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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[ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804396
Page 47 of 176
***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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
1. Repeating
Pages
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804397
Page 48 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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: //
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804398
Page 49 of 176
***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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804399
Page 50 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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?
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804400
Page 51 of 176
***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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804401
Page 52 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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?
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804402
Page 53 of 176
***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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804403
Page 54 of 176
***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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804404
Page 55 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804405
Page 56 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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:
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804406
Page 57 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804407
Page 58 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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?
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804408
Page 59 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804409
Page 60 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804410
Page 61 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804411
Page 62 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804412
Page 63 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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 [ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804413
Page 64 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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 [ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804414
Page 65 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804415
Page 66 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Not Applicable Comments
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804416
Page 67 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Applicable
//Comments
2.Primary Reason for Unblinding: Not Applicable Comments
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804417
Page 68 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Sep/30/2020
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804418
Page 69 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804419
Page 70 of 176
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/30/2020
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804420
Page 71 of 176
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804421
Page 72 of 176
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804422
Page 73 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormAug-19-2020 17:32:32 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804423
Page 74 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormAug-19-2020 17:34:48 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804424
Page 75 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormOct-29-2020 10:31:18 (UTC-05:00) Eastern Time
(US & Canada)Subject is not expected for visit 2. Subject
withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804425
Page 76 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Oct-29-2020 10:31:18 (UTC-05:00) Eastern Time
(US & Canada)Subject is not expected for visit 2. Subject withdrew
consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804426
Page 77 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Oct-29-2020 10:31:18 (UTC-05:00) Eastern Time
(US & Canada)Subject is not expected for visit 2. Subject withdrew
consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804427
Page 78 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormOct-29-2020 10:31:52 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
FormOct-29-2020 10:31:35 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804428
Page 79 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Oct-29-2020 10:31:52 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804429
Page 80 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2.aOct-29-2020 10:31:52 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804430
Page 81 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2.aOct-29-2020 10:31:52 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804431
Page 82 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2.aOct-29-2020 10:31:52 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804432
Page 83 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormOct-29-2020 10:32:19 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804433
Page 84 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Oct-29-2020 10:32:19 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804434
Page 85 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Oct-29-2020 10:32:19 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804435
Page 86 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Oct-29-2020 10:32:19 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804436
Page 87 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Oct-29-2020 10:32:19 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804437
Page 88 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Oct-29-2020 10:32:19 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804438
Page 89 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aOct-29-2020 10:32:19 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804439
Page 90 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aOct-29-2020 10:32:19 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804440
Page 91 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aOct-29-2020 10:32:19 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804441
Page 92 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormOct-29-2020 10:32:36 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804442
Page 93 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Oct-29-2020 10:32:36 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804443
Page 94 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Oct-29-2020 10:32:36 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804444
Page 95 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Oct-29-2020 10:32:36 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804445
Page 96 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Oct-29-2020 10:32:36 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804446
Page 97 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormOct-29-2020 10:32:53 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804447
Page 98 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Oct-29-2020 10:32:53 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804448
Page 99 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Oct-29-2020 10:32:53 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804449
Page 100 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Oct-29-2020 10:32:53 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804450
Page 101 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Oct-29-2020 10:32:53 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804451
Page 102 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Oct-29-2020 10:32:53 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804452
Page 103 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Oct-29-2020 10:32:53 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804453
Page 104 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
7Oct-29-2020 10:32:53 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804454
Page 105 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
8Oct-29-2020 10:32:53 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804455
Page 106 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
9Oct-29-2020 10:32:53 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804456
Page 107 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
10Oct-29-2020 10:32:53 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804457
Page 108 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
11Oct-29-2020 10:32:53 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804458
Page 109 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormNov-09-2020 11:20:54 (UTC-05:00) Eastern Time
(US & Canada)
FormOct-29-2020 10:34:05 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804459
Page 110 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Nov-09-2020 11:20:54 (UTC-05:00) Eastern Time
(US & Canada)
1Oct-29-2020 10:34:05 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804460
Page 111 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Nov-09-2020 11:20:54 (UTC-05:00) Eastern Time
(US & Canada)
2Oct-29-2020 10:34:05 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804461
Page 112 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Nov-09-2020 11:20:54 (UTC-05:00) Eastern Time
(US & Canada)
3Oct-29-2020 10:34:05 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804462
Page 113 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Nov-09-2020 11:20:54 (UTC-05:00) Eastern Time
(US & Canada)
4Oct-29-2020 10:34:05 (UTC-05:00) Eastern Time
(US & Canada)Subject withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804463
Page 114 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Nov-16-2020 14:18:48 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804464
Page 115 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormMar-03-2021 15:41:13 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804465
Page 116 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Mar-03-2021 15:41:13 (UTC-05:00) Eastern Time
(US & Canada)Not Done
1Feb-24-2021 12:17:15 (UTC-05:00) Eastern Time
(US & Canada)Karla Pentzke withdrew consent
Not Done
1Feb-23-2021 12:41:27 (UTC-05:00) Eastern Time
(US & Canada)Karla Pentzke withdrew consent
Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804466
Page 117 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Mar-03-2021 15:41:13 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804467
Page 118 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormMar-03-2021 15:30:10 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804468
Page 119 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Mar-03-2021 15:30:10 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804469
Page 120 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormOct-29-2020 10:33:23 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804470
Page 121 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Oct-29-2020 10:33:23 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804471
Page 122 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Oct-29-2020 10:33:23 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804472
Page 123 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormOct-29-2020 10:33:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804473
Page 124 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Oct-29-2020 10:33:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0804474
Page 125 of 176
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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 Nov-30-2020 11:47:01 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Howard
Schwartz Approved Nov-17-2020 11:38:02 (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.
N/A Nov-16-2020 12:49:52 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Howard
Schwartz Approved Nov-15-2020 18:26:20 (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.
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804475
Page 126 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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-19-2020 17:31:43
(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-19-2020 17:31:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804476
Page 127 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-19-2020 17:31:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/19/2020Initial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804477
Page 128 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-20-2020 10:41:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-18-2020 14:34:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered The A/E was created
Sep-18-2020 06:59:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON: AER#
2020326673
PREGNANCY (onset
date 20AUG2020)was
reported to Pfizer
Safety but missing in
AE CRF. Per protocol
All AEs/SAEs
associated with
exposure during
pregnancy or
breastfeeding should
be reported in AE
CRF. Please confirm.
Aug-19-2020 17:31:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11331207Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-19-2020 17:31:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1999Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-19-2020 17:32:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804478
Page 129 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-19-2020 17:32:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000
)Data Entry:
HISPANIC OR LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-19-2020 17:32:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN AMERICANInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804479
Page 130 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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-19-2020 17:32:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804480
Page 131 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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-19-2020 17:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-19-2020 17:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-19-2020 17:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804481
Page 132 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-19-2020 17:34:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-19-2020 17:34:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
68.9Initial Entry
3. Unit:
Date Location User Value Reason
Aug-19-2020 17:34:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-19-2020 17:34:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
159.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-19-2020 17:34:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-19-2020 17:34:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.3Initial Entry
7.a
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804482
Page 133 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Aug-19-2020 17:34:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.9
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-19-2020 17:34:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-19-2020 17:34:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-19-2020 17:34:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-19-2020 17:34:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804483
Page 134 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-19-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-19-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-19-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-19-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-19-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-19-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113Initial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804484
Page 135 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-19-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-19-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020 13:33:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Sep-18-2020 12:04:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered An Adverse Event
form was created
Sep-16-2020 10:43:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened 11331207:
Clinical_Subject had a
positive pregnancy test
after Vax 1. Per CRF
CG 8.46.2.5.
Pregnancy is to be
reported as an AE.
Please update the AE
log accordingly.
Aug-19-2020 17:34:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804485
Page 136 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-19-2020 17:33:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-19-2020 17:33:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
56917Initial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804486
Page 137 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 17:33:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 17:33:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-20-2020 16:57:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-20-2020 05:26:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-19-2020 17:33:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-19-2020 17:33:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020 16:57:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY1RDInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804487
Page 138 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Aug-20-2020 16:57:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPY1RDInitial Entry
5.b
Date Location User Value Reason
Aug-20-2020 16:57:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY1RFInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-20-2020 16:57:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPY1RFInitial Entry
5.c
Date Location User Value Reason
Aug-20-2020 16:57:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY1RGInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-20-2020 16:57:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPY1RGInitial Entry
5.d
Date Location User Value Reason
Aug-20-2020 17:00:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPFSD9Initial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804488
Page 139 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.d Sample ID
Date Location User Value Reason
Aug-20-2020 17:00:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPFSD9Initial Entry
5.e
Date Location User Value Reason
Aug-20-2020 17:00:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPFSDBInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-20-2020 17:00:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPFSDBInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804489
Page 140 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 17:33:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 17:33:50
(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-20-2020 16:59:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-20-2020 05:26:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-19-2020 17:33:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-19-2020 17:33:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020 16:59:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY1PKInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804490
Page 141 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Aug-20-2020 16:59:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPY1PKInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804491
Page 142 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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-19-2020 17:33:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-19-2020 17:33:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-19-2020 17:33:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-19-2020 17:33:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020 16:52Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-19-2020 17:33:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-19-2020 17:33:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804492
Page 143 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Aug-19-2020 17:33:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-19-2020 17:33:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-19-2020 17:33:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804493
Page 144 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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-19-2020 17:33:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000
)Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804494
Page 145 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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-29-2020 10:31:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Oct-02-2020 01:19:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-01-2020 11:55:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered subject withdrew
consent as of
30/SEP/20. No visit
will be performed.
Sep-25-2020 11:27:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly review
and complete ‘Date
of Visit, Nasal Swab,
Pregnancy Test,
Vaccination, Vital
Signs' forms at this
visit. Thank you.
2. Erroneous Visit
Date Location User Value Reason
Oct-29-2020 10:31:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804495
Page 146 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Oct-29-2020 10:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.a
Date Location User Value Reason
Oct-29-2020 10:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: Not Applica
ble
Temperature Unit: Not Applica
ble
Temperature Locati
on::Not Applica
bleInitial Entry
Oct-29-2020 10:31:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature:
Temperature Unit:
Temperature Location::Initial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-29-2020 10:31:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-29-2020 10:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2.a Unit:
Date Location User Value Reason
Oct-29-2020 10:31:52 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804496
Page 147 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00) Eastern Time
(US & Canada)Not Applicable
2.a Temperature Location:
Date Location User Value Reason
Oct-29-2020 10:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804497
Page 148 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-29-2020 10:32:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-29-2020 10:32:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-29-2020 10:32:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-29-2020 10:32:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-29-2020 10:32:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-29-2020 10:32:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defined Ide
ntifier:Not Applic
able
Test:: Not Applic
ableInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804498
Page 149 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Result:: Not Applic
able
Not Done:: Not Applic
able
6.a Sponsor ID:
Date Location User Value Reason
Oct-29-2020 10:32:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-29-2020 10:32:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-29-2020 10:32:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-29-2020 10:32:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804499
Page 150 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-29-2020 10:32:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020 10:32:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020 10:32:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-29-2020 10:32:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804500
Page 151 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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
Oct-29-2020 10:32:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-29-2020 10:32:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-29-2020 10:32:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Nov-09-2020
16:37:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedDisp EOT and FUP completed
- confirmed subj withdrew and
V2 will not occur
Nov-09-2020
16:19:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5325530;Randomization
number is recorded and the
final disposition date is
present on the Disposition -
Follow-up eCRF, but there is
no dosing date present on the
Treatment eCRF. Please
review and update as
appropriate.
Oct-29-2020
10:32:53
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Data
Entry
:
Not A
pplicaInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804501
Page 152 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Canada) ble
5. Anatomical Location:
Date Location User Value Reason
Oct-29-2020 10:32:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-29-2020 10:32:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
7. Route:
Date Location User Value Reason
Oct-29-2020 10:32:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
8. Actual Dose:
Date Location User Value Reason
Oct-29-2020 10:32:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
9. Unit:
Date Location User Value Reason
Oct-29-2020 10:32:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-29-2020 10:32:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804502
Page 153 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-29-2020 10:32:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804503
Page 154 of 176
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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
Oct-01-2020 11:58:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-01-2020 11:58:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-04-2020 18:21:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Closed per site response
Nov-04-2020 08:14:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Data is correct.
Subject withdrew
consent. Not related to
pregnancy
Nov-04-2020 07:42:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Opened CLINQUERY: EOT is
reported due to
Withdrawal by Subject
on 30Sep20. Subject
had pregnancy
reported prior to this
date. Please review
and confirm that
reason for end of
treatment was
withdrawal of consent
not related to the
pregnancy
Oct-01-2020 11:58:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WITHDRAWAL BY SUBJECTInitial Entry
4. Specify Status:
Date Location User Value Reason
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804504
Page 155 of 176
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-01-2020 11:58:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SUBJECT WITHDREW CONSENTInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804505
Page 156 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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-09-2020 16:36:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-09-2020 11:21:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Nov-09-2020 11:21:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
Nov-09-2020 11:20:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-06-2020 14:10:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Will the subject stay
in the study for
follow-up? If not,
please enter the date
and status of
discontinuation in
DISP FUP form.
Oct-29-2020 10:34:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-09-2020 11:21:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Nov-09-2020 11:20:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Oct-29-2020 10:34:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Status:
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b)(4),
(b)(6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804506
Page 157 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Nov-09-2020 11:21:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WITHDRAWAL BY SUBJECTInitial Entry
Nov-09-2020 11:20:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Oct-29-2020 10:34:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-09-2020 11:21:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Subject withdrew consentInitial Entry
Nov-09-2020 11:20:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Oct-29-2020 10:34:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804507
Page 158 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Sep-18-2020 12:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804508
Page 159 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Sep-18-2020 12:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-18-2020 12:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-17-2020 05:11:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed term updated in SDB to
maternal exposure during
pregnancy
Nov-16-2020 11:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate Pending SDB update
Nov-16-2020 09:41:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered SAE Form was updated and
faxed on Friday 11/13/2020.
Nov-10-2020 07:42:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON 2: Thank you
for updating AE CRF.
Please confirm if a follow
up AEM form was
submitted to also update the
term in Safety database to
Exposure during pregnancy.
Nov-10-2020 07:16:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered As per query
Nov-10-2020 07:16:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exposure During PregnacyAs per query
Nov-07-2020 11:31:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON 1:Per latest
update in 8.50.2.5 Specific
Guidance for Pregnancy, a
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b)(6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804509
Page 160 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
healthy Pregnancy is not an
AE that is required to be on
the CRF. “Exposure During
Pregnancy” will be recorded
as an AE log instead. Please
update accordingly.
Nov-05-2020 23:02:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate SAE RECON: For Clinical
review
Nov-05-2020 11:58:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered EDP was updated after the
preganancy not prior,
therefore, medical term
should not be updated.
Nov-03-2020 08:48:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020326673,
the term in both database
was recorded as pregnancy.
Based on the latest EDP
guidance,the term should be
reported as 'EXPOSURE
DURING PREGNANCY'.
Please confirm and
update.A follow up AEM
form is required to update
SDB.
Sep-18-2020 12:02:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PregnacyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-02-2020 09:11:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Onset date updated in SDB
to 19Aug2020
Dec-01-2020 06:45:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened SAE RECON: Thank you
for the update. However, the
onset date was still recorded
as 20Aug2020 in Safety
database. A follow up AEM
form is required to update
onset date in SDB, please
submit a follow up form.
Nov-30-2020 11:47:01
(UTC-05:00) EasternACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed Information
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804510
Page 161 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
Nov-30-2020 11:47:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020 16:52Changed Information
Nov-25-2020 05:55:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE
RECON:AER#2020326673,
per narrative "The first day
of LMP was on 19Jul2020".
Per CRF CV v10_ section
8.50.2.5 Specific Guidance
for Pregnancy, when the
participant was pregnant
before enrollment,the onset
date=date of
Vax1(19Aug2020).Please
update
Sep-22-2020 06:39:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed onset date updated in SDB
Sep-20-2020 10:46:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020345020
Sep-18-2020 12:02:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020 16:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-07-2020 14:30:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/26/2020 UNK:UNKTranscription Error
Sep-18-2020 12:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/16/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020 16:44:53
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804511
Page 162 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
Nov-16-2020 14:19:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Data updated
Nov-16-2020 14:18:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-16-2020 13:33:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Please add Item level
comment of Not
Applicable. Please
refer to CRF
Completion
Requirements section
4.10.
Nov-16-2020 12:49:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Nov-16-2020 12:49:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Changed Information
Nov-15-2020 01:36:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 1: Opened Toxicity grade is not
expected for
pregnancy related
adverse events, hence
please remove the
toxicity and add item
level comment as
NOT APPLICABLE.
Sep-18-2020 12:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-03-2020 09:03:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Deleted Close Auto Query
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804512
Page 163 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-02-2020 17:23:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 3: Closed Response satisfies
query
Oct-02-2020 15:12:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Candidate For AE Pregnacy:
Response to "Is the
adverse event
serious?" is 'No' but
"Serious Adverse
Event Number" is
present.
Oct-02-2020 15:12:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Transcription Error
Oct-02-2020 15:12:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription Error
Sep-29-2020 09:44:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 3: Opened The pregnancy was
appropriately reported
to safety; however,
seriousness criteria is
met only if there is an
abnormal pregnancy
outcome/protocol
section 8.3.5.1. Please
update seriousness
criteria accordingly.
Sep-20-2020 10:51:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Sep-18-2020 12:02:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-18-2020 12:02:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated wit
h congenital anomaly or birth defe
ct?
NO
Did this serious event result in deat
h?
NOTranscription Error
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804513
Page 164 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Did this serious event require or pr
olong hospitalization?
NO
Did this serious event result in pers
istent or significant disability/incap
acity?
NO
Is this serious event life threatenin
g?
NO
Other medically important serious
event
YES
Sep-18-2020 12:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate For AE Pregnacy:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Sep-18-2020 12:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Is the adverse event
serious?' is marked as
YES, but responses to
all of the seriousness
criteria are NO. At
least one seriousness
criterion is expected to
be YES for serious
events. Please review
and update as
appropriate.
Sep-18-2020 12:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated wit
h congenital anomaly or birth defe
ct?
NO
Did this serious event result in deat
h?Initial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804514
Page 165 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
NO
Did this serious event require or pr
olong hospitalization?
NO
Did this serious event result in pers
istent or significant disability/incap
acity?
NO
Is this serious event life threatenin
g?
NO
Other medically important serious
event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-18-2020 12:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-18-2020 12:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s),
this event is due to:
OTHER
If Other, specify:
PregnacyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804515
Page 166 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-18-2020 12:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-18-2020 12:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-18-2020 12:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-03-2020 09:04:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed To confirm with PSSR if acceptable
discrepancy per case processing
convention
Sep-23-2020 05:35:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE
RECON:AER#2020326673 ,outcome
was reported as UNKNOWN in
SAE form however, recorded as
RECOVERED/RESOLVED on AE
CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804516
Page 167 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-22-2020 11:11:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Closed GPDClin: Closed this query as it
was raised based on a wrong SAE
case number. The correct SAE case
number for this case is 2020326673.
Sep-20-2020 10:50:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020345020 ,outcome
was reported as UNKNOWN in
SAE form however, recorded as
RECOVERED/RESOLVED on AE
CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Sep-18-2020 12:02:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-18-2020 12:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-03-2020 09:03:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: downgraded to No in
Inform and not serious
in SDB but valid
case.. As per Safety
when no adverse is
reported in an
Exposure During
Pregnancy case report,
the Case seriousness is
captured as
Non-Serious. The case
is retained as a valid
case report in SDB
Sep-22-2020 07:05:56 ACV0PFEINFP6000 Data Entry: AER corrected
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804517
Page 168 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00) Eastern Time
(US & Canada)2020326673
Sep-20-2020 10:51:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2020345020Initial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804518
Page 169 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021
09:01:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedResponse satisfies query
Mar-03-2021
15:41:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
Answere
dChanged data per query
Feb-24-2021
20:03:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Rivkah Rosen Query 1:
Reissued
:OpenedDM: If REVAX CONT
was not done, please
consider removing all data
from corresponding forms,
e.g., from REVAX CONF
and mark forms with 'Not
Applicable' using a
form-level comment.
Feb-24-2021
12:17:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Karla Pentzke Query 1:
Answere
dChanged data per query
Feb-24-2021
12:17:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Karla Pentzke Data En
try:
Not Don
eInitial Entry
Feb-24-2021
07:31:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1:
OpenedDMW7403156;FURTHER
VACCINATION
CONFIRMATION CRF is
completed, however date
of visit is missing for
REVAX_CONTACT.
Please review and update
as appropriate.
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804519
Page 170 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Feb-23-2021
12:41:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Karla Pentzke Data En
try:
Not Appl
icableInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-03-2021 15:41:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804520
Page 171 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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
Mar-03-2021 15:30:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Mar-03-2021 15:29:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Feb-23-2021 12:41:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Karla Pentzke Data Entry:
Participant is NOT willing to return f
or Vaccination 3 OR otherwise not el
igibleInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804521
Page 172 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Oct-29-2020 10:33:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Oct-29-2020 10:33:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804522
Page 173 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - 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: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Nov-12-2020 07:49:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-09-2020 11:21:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per query
Nov-06-2020 20:05:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: If subject is
completely withdrawn
from the study, please
complete the
Disposition Follow up
CRF. Refer to CCR
section 8.56 for
information/guidance.
Oct-01-2020 11:55:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804523
Page 174 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Oct-29-2020 10:33:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804524
Page 175 of 176
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-09-2020 11:21:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-01-2020 11:58:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Aug-19-2020 17:33:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-19-2020 17:32:54
(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-09-2020 11:21:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/30/2020Initial Entry
Oct-01-2020 11:58:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/30/2020Initial Entry
Aug-19-2020 17:33:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
Aug-19-2020 17:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804525
Page 176 of 176
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331207 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 07:45:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3ef6\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804526