Document text
Page 1 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792275
Page 2 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/18/2020
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792276
Page 3 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11141050]
2.Birth Date: /1956
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792277
Page 4 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/18/2020
2.Erroneous Visit
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792278
Page 5 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792279
Page 6 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792280
Page 7 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Presbyopia]
Start Date: Jan/1/1973
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hearing Loss]
Start Date: Jan/1/1991
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: Jan/1/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sleep Apnea]
Start Date: Jan/1/2016
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Postmenopausal]
Start Date: Jan/1/2000
Ongoing: YES
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792281
Page 8 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoporosis Generalized]
Start Date: Jan/1/2010
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Rheumatoid Arthritis-Generalized]
Start Date: Jan/1/2010
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Degenerative Disc Disease]
Start Date: Aug/18/2005
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Rotator Cuff Tear]
Start Date: Jul/1/2016
Ongoing: NO
End Date:
Aug/1/2016
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: Jan/1/1984
Ongoing: YES
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792282
Page 9 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Rotator Cuff Repair]
Start Date: Aug/1/2016
Ongoing: NO
End Date:
Aug/1/2016
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792283
Page 10 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Aug/18/2020
2.Weight: [74.1]
3.Unit: kg
4.Height: [165.0]
5.Unit: cm
6.Body Mass Index: [27.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792284
Page 11 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/18/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792285
Page 12 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/18/2020
2.Randomization Number: [232517]
3.Randomization Group: [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792286
Page 13 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/18/2020
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 [BPR785]
5.bSample ID [BPR786]
5.cSample ID [BP5FLZ]
5.dSample ID [BP5FM0]
5.eSample ID [BP5FM1]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792287
Page 14 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/18/2020
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 [BP5FL4]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792288
Page 15 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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/18/2020 15:53
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
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792289
Page 16 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792290
Page 17 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792291
Page 18 of 137
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792292
Page 19 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/8/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792293
Page 20 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
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 [BP5FZC]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792294
Page 21 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/8/2020 15:45
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
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792295
Page 22 of 137
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792296
Page 23 of 137
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
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 [BPR7H3]
5.bSample ID [BPR7H4]
5.cSample ID [BP5G40]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792297
Page 24 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792298
Page 25 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792299
Page 26 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792300
Page 27 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792301
Page 28 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792302
Page 29 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792303
Page 30 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792304
Page 31 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792305
Page 32 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792306
Page 33 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792307
Page 34 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792308
Page 35 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792309
Page 36 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792310
Page 37 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792311
Page 38 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792312
Page 39 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792313
Page 40 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/7/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792314
Page 41 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Oct/19/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792315
Page 42 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792316
Page 43 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792317
Page 44 of 137
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 Sudden cardiac de
ath Oct/19/2020 UNK:U
NK NO
End Date Time:
Oct/19/2020 UNK:UNK
Repeating
Pages
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792318
Page 45 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[Sudden cardiac death]
4.Start Date Time: Oct/19/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/19/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792319
Page 46 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2020468218]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792320
Page 47 of 137
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792321
Page 48 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792322
Page 49 of 137
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792323
Page 50 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: //
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792324
Page 51 of 137
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792325
Page 52 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792326
Page 53 of 137
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792327
Page 54 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792328
Page 55 of 137
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792329
Page 56 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792330
Page 57 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792331
Page 58 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792332
Page 59 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792333
Page 60 of 137
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792334
Page 61 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792335
Page 62 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792336
Page 63 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792337
Page 64 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792338
Page 65 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792339
Page 66 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792340
Page 67 of 137
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792341
Page 68 of 137
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792342
Page 69 of 137
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792343
Page 70 of 137
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792344
Page 71 of 137
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Nov/25/2020
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Currently unknown-pending records]
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792345
Page 72 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/19/2020
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792346
Page 73 of 137
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792347
Page 74 of 137
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Richard Glover Approved Jan-25-2021 11:09:35 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardGlover, 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.
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792348
Page 75 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-18-2020 17:57:02 (UTC-06:00) Central Time
(US & Canada)Not Applicable
Not Applicable
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0792349
Page 76 of 137
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Richard Glover Approved Jan-25-2021 11:09:35 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardGlover, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-09-2020 16:17:31 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Glover Approved Dec-02-2020 13:39:48 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardGlover, 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-25-2020 18:51:46 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Glover Approved Oct-21-2020 14:26:17 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792350
Page 77 of 137
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Affidavit:
By my dated signature below, I, RichardGlover, 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.
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792351
Page 78 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-18-2020 17:55:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-18-2020 17:55:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792352
Page 79 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-18-2020 17:55:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/18/2020Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792353
Page 80 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-18-2020 17:56:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-18-2020 17:56:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
11141050Transcription Error
Aug-18-2020 17:55:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Subject ID is
expected to be in 8
digits. Please review.
Aug-18-2020 17:54:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1141050Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-18-2020 17:54:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1956Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-18-2020 17:55:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-18-2020 17:55:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-18-2020 17:55:57 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0792354
Page 81 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central Time
(US & Canada)WHITE
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0792355
Page 82 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-18-2020 17:56:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792356
Page 83 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-18-2020 17:57:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-18-2020 17:57:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-18-2020 17:57:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792357
Page 84 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Aug-18-2020 17:59:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term: Presbyopia
Start Date: Jan/1/1973
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-18-2020 17:59:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 17:59:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PresbyopiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-18-2020 17:59:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/1973Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-18-2020 17:59:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-18-2020 18:00:11
(UTC-06:00) Central TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792358
Page 85 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(US & Canada) Medical History Term
:Hearing Los
s
Start Date: Jan/1/1991
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Aug-18-2020 18:00:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 18:00:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Hearing LossInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-18-2020 18:00:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/1991Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-18-2020 18:00:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-18-2020 18:01:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Term
:Hypertensio
n
Start Date: Jan/1/2010
Ongoing: YESInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792359
Page 86 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.c Line/MH Number:
Date Location User Value Reason
Aug-18-2020 18:01:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 18:01:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-18-2020 18:01:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-18-2020 18:01:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-18-2020 18:02:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Term
:Sleep Apne
a
Start Date: Jan/1/2016
Ongoing: YESInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792360
Page 87 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.d Line/MH Number:
Date Location User Value Reason
Aug-18-2020 18:02:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 18:02:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sleep ApneaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-18-2020 18:02:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-18-2020 18:02:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-18-2020 18:02:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:Postmenopaus
al
Start Date: Jan/1/2000
Ongoing: YESInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792361
Page 88 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.e Line/MH Number:
Date Location User Value Reason
Aug-18-2020 18:02:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 18:02:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PostmenopausalInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-18-2020 18:02:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2000Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-18-2020 18:02:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-20-2020 16:24:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:6
Medical History
Term:Osteoporosis Gen
eralized
Start Date: Jan/1/2010
Ongoing: YESChanged Information
Aug-18-2020 18:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:Osteoporosi
s
Start Date: Jan/1/2010
Ongoing: YESInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792362
Page 89 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.f Line/MH Number:
Date Location User Value Reason
Aug-18-2020 18:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 16:24:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Osteoporosis GeneralizedChanged Information
Aug-18-2020 18:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OsteoporosisInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-18-2020 18:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2010Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-18-2020 18:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-19-2020 15:51:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:7
Medical Histo
ry Term:Rheumatoid Arthriti
s-Generalized
Start Date: Jan/1/2010
Ongoing: YESCorrect info entered
and PI confirmed
stable pt prior to
enrollment
Aug-18-2020 18:04:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792363
Page 90 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Medical History
Term:Rheumatoid Art
hritis
Start Date: Jan/1/2010
Ongoing: YES
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792364
Page 91 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.g Line/MH Number:
Date Location User Value Reason
Aug-18-2020 18:04:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 13:55:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-19-2020 15:51:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Correct info entered
and PI confirmed
stable pt prior to
enrollment
Aug-19-2020 15:51:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Rheumatoid Arthritis-GeneralizedCorrect info entered
and PI confirmed
stable pt prior to
enrollment
Aug-19-2020 13:01:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN - Please
confirm
RHEUMATOID
ARTHRITIS was
stable prior to
enrollment and subject
was not receiving
systemic steroids for
this condition 28 Days
prior to study with
exception of Inhaled
Steroids.
Aug-18-2020 18:04:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Rheumatoid ArthritisInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-24-2020 11:09:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Samuel
DychterQuery 2: Closed Response satisfies
query
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0792365
Page 92 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-21-2020 11:21:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-21-2020 08:41:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Patient is not currently
taking any
Immunosuppressive
medications
Aug-20-2020 18:09:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Samuel
DychterQuery 2: Opened GPDClin: Please
confirm if the subject
is currently taking
immunosuppressive
medication for the RA.
Aug-20-2020 16:23:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered As per source the body
site/location is
Generalized no other
data is present
Aug-20-2020 13:57:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Query intent is to
specify the body
site/location of the
condition. (ex - Knee,
Hip, ex) Please update
as applicable.
Aug-19-2020 15:52:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Medical term for
Osteoarthritis has been
updated
Aug-19-2020 13:02:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN - Body
site/locationis not
provided. Please
specify body
site/location of RA.
Aug-18-2020 18:04:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2010Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-18-2020 18:04:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0792366
Page 93 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.h
Date Location User Value Reason
Aug-18-2020 18:05:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:Degenerative Dis
c Disease
Start Date: Aug/18/2005
Ongoing: YESTranscription Error
Aug-18-2020 18:05:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:Degenerative Dis
c Disease
Start Date: Aug/18/2020
Ongoing: YESInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792367
Page 94 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.h Line/MH Number:
Date Location User Value Reason
Aug-18-2020 18:05:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 18:05:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Degenerative Disc DiseaseInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-18-2020 18:05:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-18-2020 18:05:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2005Transcription Error
Aug-18-2020 18:05:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
18/Aug/2020. Please
review and update as
appropriate.
Aug-18-2020 18:05:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-18-2020 18:05:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792368
Page 95 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-18-2020 18:06:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:9
Medical History
Term:Right Rotator Cuf
f Tear
Start Date: Jul/1/2016
Ongoing: NO
End Date:
Aug/1/2016Initial Entry
1.i Line/MH Number:
Date Location User Value Reason
Aug-18-2020 18:06:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 18:06:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Right Rotator Cuff TearInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-18-2020 18:06:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/1/2016Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-18-2020 18:06:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/1/2016Initial Entry
1.j
Date Location User Value Reason
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792369
Page 96 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-18-2020 18:07:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Term: Depression
Start Date: Jan/1/1984
Ongoing: YESInitial Entry
1.j Line/MH Number:
Date Location User Value Reason
Aug-18-2020 18:07:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 18:07:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DepressionInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-18-2020 18:07:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/1984Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-18-2020 18:07:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Aug-18-2020 18:08:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:11
Medical History
Term:Right Rotator Cuff
Repair
Start Date: Aug/1/2016Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792370
Page 97 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Ongoing: NO
End Date:
Aug/1/2016
1.k Line/MH Number:
Date Location User Value Reason
Aug-18-2020 18:08:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 18:08:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Right Rotator Cuff RepairInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-18-2020 18:08:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/1/2016Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-18-2020 18:08:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/1/2016Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792371
Page 98 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Aug-18-2020 17:57:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-18-2020 17:57:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
74.1Initial Entry
3. Unit:
Date Location User Value Reason
Aug-18-2020 17:57:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-18-2020 17:57:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
165.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-18-2020 17:57:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-18-2020 17:57:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.2Initial Entry
7.a
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792372
Page 99 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-18-2020 17:57:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 37.4
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-18-2020 17:57:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-18-2020 17:57:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
37.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-18-2020 17:57:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-18-2020 17:57:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792373
Page 100 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-18-2020 17:58:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-18-2020 17:58:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-18-2020 17:58:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-18-2020 17:58:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-18-2020 17:58:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-18-2020 17:58:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792374
Page 101 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Aug-18-2020 17:58:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-18-2020 17:58:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-18-2020 17:58:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792375
Page 102 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-18-2020 17:58:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-18-2020 17:58:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
232517Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792376
Page 103 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 08:48:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 08:48:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020 08:49:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020 08:48:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-19-2020 08:48:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020 08:49:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR785Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792377
Page 104 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-19-2020 08:49:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPR785Initial Entry
5.b
Date Location User Value Reason
Aug-19-2020 08:49:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR786Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-19-2020 08:49:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPR786Initial Entry
5.c
Date Location User Value Reason
Aug-19-2020 08:50:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5FLZInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-19-2020 08:50:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP5FLZInitial Entry
5.d
Date Location User Value Reason
Aug-19-2020 08:50:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5FM0Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792378
Page 105 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Aug-19-2020 08:50:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP5FM0Initial Entry
5.e
Date Location User Value Reason
Aug-19-2020 08:50:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5FM1Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-19-2020 08:50:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP5FM1Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792379
Page 106 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 08:49:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 08:49:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020 08:50:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020 08:49:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-19-2020 08:49:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020 08:50:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5FL4Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792380
Page 107 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-19-2020 08:50:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP5FL4Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792381
Page 108 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-18-2020 17:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-18-2020 17:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-18-2020 17:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-18-2020 17:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020 15:53Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-18-2020 17:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-18-2020 17:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792382
Page 109 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-18-2020 17:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-18-2020 17:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-18-2020 17:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792383
Page 110 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-18-2020 17:59:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792384
Page 111 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020 16:24:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792385
Page 112 of 137
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020 16:24:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
2.a
Date Location User Value Reason
Sep-08-2020 16:24:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.4
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-08-2020 16:24:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-08-2020 16:24:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-08-2020 16:24:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792386
Page 113 of 137
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-08-2020 16:24:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792387
Page 114 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-08-2020 16:25:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-08-2020 16:25:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-08-2020 16:25:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-08-2020 16:25:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-08-2020 16:25:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-08-2020 16:25:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792388
Page 115 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Sep-08-2020 16:25:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-08-2020 16:25:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-08-2020 16:25:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792389
Page 116 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 16:26:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 16:26:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020 16:26:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-08-2020 16:26:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-08-2020 16:26:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020 16:26:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5FZCInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792390
Page 117 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-08-2020 16:26:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP5FZCInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792391
Page 118 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-08-2020 16:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020 16:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020 16:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-08-2020 16:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020 15:45Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020 16:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-08-2020 16:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792392
Page 119 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-08-2020 16:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-08-2020 16:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-08-2020 16:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792393
Page 120 of 137
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020 13:43:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792394
Page 121 of 137
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020 13:44:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020 13:44:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020 13:44:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-07-2020 13:44:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-07-2020 13:44:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020 13:44:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR7H3Transcription Error
Oct-07-2020 13:44:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR7H34Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792395
Page 122 of 137
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Oct-07-2020 13:44:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-07-2020 13:44:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPR7H3Transcription Error
Oct-07-2020 13:44:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in length.
Please review and
correct as appropriate.
Oct-07-2020 13:44:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPR7H34Initial Entry
5.b
Date Location User Value Reason
Oct-07-2020 13:44:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR7H4Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-07-2020 13:44:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPR7H4Initial Entry
5.c
Date Location User Value Reason
Oct-07-2020 13:58:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5G40Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792396
Page 123 of 137
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.c Sample ID
Date Location User Value Reason
Oct-07-2020 13:58:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP5G40Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792397
Page 124 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-08-2020 11:16:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-08-2020 11:16:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-08-2020 11:16:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792398
Page 125 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-25-2020 19:10:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-25-2020 19:10:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Nov-25-2020 19:10:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DEATHInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792399
Page 126 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Nov-25-2020 18:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792400
Page 127 of 137
***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, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Nov-25-2020 18:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-25-2020 18:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Dec-15-2020
04:49:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Clo
sedResponse satisfies query
Dec-14-2020
09:49:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Ans
weredSudden cardiac death is the
cause, and the outcome is
set at fatal
Dec-11-2020
05:34:05
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedResponse satisfies query
Dec-10-2020
14:09:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
3: Op
enedDMW6428151;This
'Adverse Event' contains the
term DEATH. If known,
please provide the cause of
death as the AE term with
an outcome of FATAL or
clarify.
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0792401
Page 128 of 137
***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, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Dec-09-2020
16:17:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Ans
weredNew Information
Dec-09-2020
16:17:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Del
etedNew Information
Dec-09-2020
16:17:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Sudde
n card
iac de
athNew Information
Dec-09-2020
06:53:36
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Op
enedSAE
RECON:AER#2020468218,
the term in Safety database
was updated to Sudden
cardiac death while retained
as death-cause unknownin
AE CRF.Please confirm
correct term. If safety
update is required, please
submit a follow-up form.
Nov-29-2020
22:47:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Candi
dateto follow up: pending
records
Nov-27-2020
09:18:48
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredCorrect as entered pending
records
Nov-26-2020
02:34:36
(UTC-06:00)
Central TimeACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6247063;This
'Adverse Event' contains the
term DEATH. If known,
please provide the cause of
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792402
Page 129 of 137
***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, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(US &
Canada)death as the AE term with
an outcome of FATAL or
clarify.
Nov-25-2020
18:51:46
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
death-
cause
unkno
wnInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-25-2020 18:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-25-2020 18:58:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/19/2020 UNK:UNKTranscription Error
Nov-25-2020 18:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-25-2020 18:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792403
Page 130 of 137
***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, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-27-2020 03:32:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-25-2020 23:50:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened For AE death-cause
unknown: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Nov-25-2020 18:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE death-cause
unknown: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Nov-25-2020 18:51:46
(UTC-06:00) Central 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 dea
th?
YES
Did this serious event require or pr
olong hospitalization?
NO
Did this serious event result in per
sistent or significant disability/inc
apacity?
NO
Is this serious event life threatenin
g?
NO
Other medically important seriousInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792404
Page 131 of 137
***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, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
Nov-25-2020 18:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-25-2020 18:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s)
, this event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-25-2020 18:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-25-2020 18:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-25-2020 18:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792405
Page 132 of 137
***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, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-29-2020
23:12:52
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Cl
osedResponse satisfies
query
Nov-27-2020
16:26:00
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: A
nsweredDISP pg lists Death.
Please Advise if
needs to be
recorded elsewhere
Nov-26-2020
23:27:42
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 3: O
penedDMW6246975;The
outcome of this AE
is selected as
FATAL, but there
are no Disposition
eCRFs with a
'Status' of DEATH.
Please review and
update as
appropriate.
Nov-25-2020
19:03:29
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Cl
osedClose Auto Query
Nov-25-2020
18:58:40
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Cl
osedClose Auto Query
Nov-25-2020
18:51:46
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: O
penedResponse to "What
was the outcome of
this adverse event?"
is 'Fatal' but Date of
Collection /
Notification of
Death on the Death
Details form is not
completed. Please
review and update
as appropriate.
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0792406
Page 133 of 137
***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, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-25-2020
18:51:46
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: O
penedFor AE death-cause
unknown: Response
to "What was the
outcome of this
adverse event?" is
'Fatal' but "Is the
adverse event still
ongoing?" is
marked 'Yes'.
Nov-25-2020
18:51:46
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
FATALInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-25-2020 18:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-27-2020 03:32:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2020468218Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792407
Page 134 of 137
***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, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Nov-26-2020 00:26:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Nov-25-2020 19:12:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Yes because we were
notified after they died.
Nov-25-2020 19:10:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of Collection /
Notification of Death is
greater than the Date of
Completion/Discontinuation
/Death on the Disposition
form 19/Oct/2020. Please
review and update as
appropriate
Nov-25-2020 19:03:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/25/2020Initial Entry
2.a
Date Location User Value Reason
Nov-25-2020 19:04:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Cause of Dea
th Status:PRIMARY CAUSE
OF DEATH
Cause of Dea
th:Currently unknown-
pending recordsInitial Entry
2.a Cause of Death Status:
Date Location User Value Reason
Nov-25-2020 19:04:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CAUSE OF DEATHInitial Entry
2.a Cause of Death:
Date Location User Value Reason
Mar-12-2021 15:53:22 ACV0PFEINFP6000 Query 1: Closed Response satisfies
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792408
Page 135 of 137
***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, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central Time
(US & Canada)query
Mar-12-2021 15:07:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered We are still awaiting
records from the
coroner
Mar-12-2021 01:07:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY: please
clarify if there has
been any update
regarding the pending
records.
Mar-11-2021 14:59:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Candidate CLINQUERY: please
clarify if there has
been any update
regarding the pending
records.
Nov-25-2020 19:04:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Currently unknown-pending record
sInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792409
Page 136 of 137
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-25-2020 19:10:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-08-2020 11:16:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-18-2020 17:58:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-18-2020 17:57:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-25-2020 19:10:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/19/2020Initial Entry
Oct-08-2020 11:16:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
Aug-18-2020 17:58:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
Aug-18-2020 17:57:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792410
Page 137 of 137
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020 08:41:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3d50\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792411