Document text
Page 1 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896462
Page 2 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/1/2020
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896463
Page 3 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10191145]
2.Birth Date: 1981
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:
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896464
Page 4 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896465
Page 5 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896466
Page 6 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896467
Page 7 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myopia]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/2008
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Cough]
Start Date: Mar/UNK/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hemorrhoids]
Start Date: UNK/UNK/2011
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hemorrhoids]
Start Date: UNK/UNK/2011
Ongoing: YES
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896468
Page 8 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Herpes Simplex Virus Type II]
Start Date: UNK/UNK/2018
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Nasal Fracture]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Herniated Lumbar Discs]
Start Date: UNK/UNK/2012
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Iron Deficiency Anemia]
Start Date: UNK/UNK/2013
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Eczema]
Start Date: UNK/UNK/1998
Ongoing: YES
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896469
Page 9 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic Rhinitis]
Start Date: UNK/UNK/2010
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Septoplasty]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Laminoectomy]
Start Date: Aug/UNK/2013
Ongoing: NO
End Date:
Aug/UNK/2013
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cosmetic Breast Reduction]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896470
Page 10 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Breast Augmentation]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896471
Page 11 of 372
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
2.Weight: [141.7]
3.Unit: LB
4.Height: [66.0]
5.Unit: in
6.Body Mass Index: [22.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: EAR
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896472
Page 12 of 372
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/1/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896473
Page 13 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/1/2020
2.Randomization Number: [75488]
3.Randomization Group: [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896474
Page 14 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP98BX]
5.bSample ID [BP98BY]
5.cSample ID [BP98BZ]
5.dSample ID [BPRMD1]
5.eSample ID [BPRMD2]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896475
Page 15 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM864M]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896476
Page 16 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/1/2020 14:46
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
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896477
Page 17 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896478
Page 18 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896479
Page 19 of 372
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: EAR
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896480
Page 20 of 372
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/23/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896481
Page 21 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP98MT]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896482
Page 22 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/23/2020 14:14
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
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896483
Page 23 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896484
Page 24 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
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 [BR85RR]
5.bSample ID [BRTM13]
5.cSample ID [BRTM14]
5.dSample ID [BRTM15]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896485
Page 25 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896486
Page 26 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896487
Page 27 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896488
Page 28 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896489
Page 29 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896490
Page 30 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896491
Page 31 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Answered Queries, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896492
Page 32 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Answered Queries
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/18/2021
2.Date of First Symptom Started: Jan/17/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/21/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896493
Page 33 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Answered Queries
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
5.bSymptoms - Other Text: [Fatigue]
5.cSymptoms - Other Text: [Runny Nose]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896494
Page 34 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Jan/19/20
21 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896495
Page 35 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/19/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [unknown]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896496
Page 36 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Subject never sent in self-swab.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896497
Page 37 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Subject self swabbed.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896498
Page 38 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896499
Page 39 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896500
Page 40 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896501
Page 41 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896502
Page 42 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable
Repeating Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896503
Page 43 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896504
Page 44 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable
Not Appli
cable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896505
Page 45 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896506
Page 46 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896507
Page 47 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896508
Page 48 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896509
Page 49 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.Not Applicabl
e Not Applicable Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896510
Page 50 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896511
Page 51 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896512
Page 52 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896513
Page 53 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896514
Page 54 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896515
Page 55 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896516
Page 56 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896517
Page 57 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896518
Page 58 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896519
Page 59 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896520
Page 60 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896521
Page 61 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896522
Page 62 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896523
Page 63 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896524
Page 64 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896525
Page 65 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896526
Page 66 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896527
Page 67 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896528
Page 68 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896529
Page 69 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896530
Page 70 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896531
Page 71 of 372
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896532
Page 72 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896533
Page 73 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896534
Page 74 of 372
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Ductal carcinoma righ
t Breast Nov/13/2020 UN
K:UNK YES Repeating
Pages
2.ADVERSE EV
ENT 2 Ductal Carcinoma Lef
t Breast Nov/13/2020 UN
K:UNK YES Repeating
Pages
3.ADVERSE EV
ENT 3 Right Axillary Metast
ases Nov/13/2020 UN
K:UNK YES Repeating
Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896535
Page 75 of 372
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Ductal carcinoma right Breast]
4.Start Date Time: Nov/13/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
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?
NO
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
YES
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
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896536
Page 76 of 372
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[Idiopathic.]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020457291]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896537
Page 77 of 372
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Ductal Carcinoma Left Breast]
4.Start Date Time: Nov/13/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
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?
NO
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
YES
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
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896538
Page 78 of 372
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[idiopathic]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020457291]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896539
Page 79 of 372
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Right Axillary Metastases]
4.Start Date Time: Nov/13/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
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?
NO
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
YES
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
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896540
Page 80 of 372
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[finding]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020457291]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896541
Page 81 of 372
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896542
Page 82 of 372
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896543
Page 83 of 372
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896544
Page 84 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896545
Page 85 of 372
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1.[ ] [ ] [ ] Repeating
Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896546
Page 86 of 372
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Queries, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
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?
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896547
Page 87 of 372
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896548
Page 88 of 372
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896549
Page 89 of 372
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896550
Page 90 of 372
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896551
Page 91 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896552
Page 92 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896553
Page 93 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896554
Page 94 of 372
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896555
Page 95 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896556
Page 96 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896557
Page 97 of 372
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896558
Page 98 of 372
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896559
Page 99 of 372
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896560
Page 100 of 372
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896561
Page 101 of 372
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896562
Page 102 of 372
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896563
Page 103 of 372
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/30/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896564
Page 104 of 372
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896565
Page 105 of 372
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896566
Page 106 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/22/2020
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896567
Page 107 of 372
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896568
Page 108 of 372
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896569
Page 109 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-01-2020 15:52:25 (UTC-06:00) Central
Time (US & Canada)n/a
Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896570
Page 110 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-29-2021 09:29:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896571
Page 111 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-29-2021 09:29:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896572
Page 112 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-29-2021 09:29:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896573
Page 113 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-29-2021 09:29:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896574
Page 114 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-29-2021 09:29:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896575
Page 115 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Jan-29-2021 09:29:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896576
Page 116 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Jan-29-2021 09:29:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896577
Page 117 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-29-2021 09:30:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896578
Page 118 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-29-2021 09:30:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896579
Page 119 of 372
***Confidential***
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ItemDate User Comment
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
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Time (US & Canada)Not Applicable
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1019 Site Name: (1019) Diagnostics Research Group
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(b) (4),
(b) (6)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
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090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
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Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
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Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0896586
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
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Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
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Back to Form
ItemDate User Comment
5.aJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0896589
Page 129 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0896590
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
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Back to Form
ItemDate User Comment
5.aJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0896591
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
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Back to Form
ItemDate User Comment
5.bJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0896592
Page 132 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
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Back to Form
ItemDate User Comment
5.bJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0896593
Page 133 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
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Back to Form
ItemDate User Comment
5.bJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0896594
Page 134 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
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Back to Form
ItemDate User Comment
5.bJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0896595
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
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Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0896596
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
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Back to Form
ItemDate User Comment
5.cJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0896597
Page 137 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
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Back to Form
ItemDate User Comment
5.cJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0896598
Page 138 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
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Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0896599
Page 139 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
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(b) (4),
(b) (6)
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Page 140 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
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(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0896601
Page 141 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-29-2021 09:30:17 (UTC-06:00) Central
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(b) (4),
(b) (6)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
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(b) (4),
(b) (6)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
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(b) (6)
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FDA-CBER-2021-5683-0896606
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
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(b) (6)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
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(b) (6)
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FDA-CBER-2021-5683-0896608
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0896609
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0896610
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-29-2021 09:30:17 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
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090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
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090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
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090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
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Time (US & Canada)Not Applicable
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
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ItemDate User Comment
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
5.eJan-29-2021 09:30:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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ItemDate User Comment
5 fJan-29-2021 09:30:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10191145 Subject Initials: ---
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ItemDate User Comment
5 fJan-29-2021 09:30:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
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Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-29-2021 09:31:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896676
Page 216 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-29-2021 09:31:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896677
Page 217 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-29-2021 09:31:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896678
Page 218 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Jan-29-2021 09:31:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896679
Page 219 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Jan-29-2021 09:31:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896680
Page 220 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-29-2021 09:31:49 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896681
Page 221 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-29-2021 09:31:49 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896682
Page 222 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-29-2021 09:31:49 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896683
Page 223 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-29-2021 09:31:49 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896684
Page 224 of 372
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/18/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-29-2021 09:31:49 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896685
Page 225 of 372
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-12-2021 10:23:45 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-05-2021 18:53:31 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-28-2021 10:07:42 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Dec-03-2020 13:59:07 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896686
Page 226 of 372
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
N/A Nov-19-2020 13:05:19 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-26-2020 13:16:12 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896687
Page 227 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-01-2020 15:51:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-01-2020 15:51:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896688
Page 228 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-01-2020 15:51:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/1/2020Initial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896689
Page 229 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-01-2020 15:51:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10191145Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-01-2020 15:51:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1981Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-01-2020 15:52:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-01-2020 15:52:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-01-2020 15:52:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896690
Page 230 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-01-2020 15:52:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896691
Page 231 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-01-2020 15:52:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-01-2020 15:52:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-01-2020 15:52:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896692
Page 232 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-01-2020 15:53:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Myopia
Start Date: UNK/UNK/199
0
Ongoing: NO
End Date:
UNK/UNK/
2008Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:53:52
(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
Nov-08-2020 07:33:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Myopia has been
coded.
Nov-03-2020 16:12:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Candidate DM: DO NOT
ISSUE QUERY.
Site request to
update. Query can
be closed after
updates made and
coding complete.
Sep-01-2020 15:53:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MyopiaInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896693
Page 233 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.a Start Date:
Date Location User Value Reason
Sep-01-2020 15:53:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-01-2020 15:53:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
1.b
Date Location User Value Reason
Sep-01-2020 15:54:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:Chronic Cou
gh
Start Date: Mar/UNK/20
20
Ongoing: YESInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896694
Page 234 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:54:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020 10:34:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-03-2020 07:35:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered unknown cause
Sep-02-2020 06:15:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN: Chronic
cough has a recent
start date. Please
clarify if there is a
known cause or if
further workup was
indicated.
Sep-01-2020 15:54:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Chronic CoughInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-01-2020 15:54:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/UNK/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-01-2020 15:54:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0896695
Page 235 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c
Date Location User Value Reason
Sep-01-2020 15:54:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Hemorrhoids
Start Date: UNK/UNK/2
011
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:54:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 15:54:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HemorrhoidsInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-01-2020 15:54:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-01-2020 15:54:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896696
Page 236 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-01-2020 15:54:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:Hemorrhoids
Start Date: UNK/UNK/2
011
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:54:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 15:54:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HemorrhoidsInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-01-2020 15:54:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-01-2020 15:54:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896697
Page 237 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-01-2020 15:55:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Histo
ry Term:Herpes Simplex V
irus Type II
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896698
Page 238 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:55:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020 10:34:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-08-2020 08:29:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered no systemic
anti-viral treatment
Sep-06-2020 09:37:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN: Please
confirm no
systemic anti-viral
treatment.
Sep-01-2020 15:55:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Herpes Simplex Virus Type IIInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-01-2020 15:55:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-01-2020 15:55:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0896699
Page 239 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-01-2020 15:55:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:Nasal Fracture
Start Date: UNK/UNK/201
7
Ongoing: NO
End Date:
UNK/UNK/
2017Initial Entry
1.f Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:55:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 15:55:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nasal FractureInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-01-2020 15:55:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-01-2020 15:55:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896700
Page 240 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g
Date Location User Value Reason
Sep-01-2020 15:56:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:Herniated Lumb
ar Discs
Start Date: UNK/UNK/201
2
Ongoing: YESInitial Entry
1.g Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:56:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 15:56:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Herniated Lumbar DiscsInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-01-2020 15:56:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-01-2020 15:56:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896701
Page 241 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-01-2020 15:57:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histo
ry Term:Iron Deficienc
y Anemia
Start Date: UNK/UNK/20
13
Ongoing: YESTranscription Error
Sep-01-2020 15:57:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:
Medical History
Term:
Start Date: UNK/UNK/
2013
Ongoing: YESTranscription Error
Sep-01-2020 15:57:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:
Medical History
Term:
Start Date: UNK/UNK/
2012
Ongoing: YESTranscription Error
Sep-01-2020 15:56:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histo
ry Term:Herniated Lum
bar Discs
Start Date: UNK/UNK/20
12
Ongoing: YESInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896702
Page 242 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:57:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Transcription Error
Sep-01-2020 15:57:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Sep-01-2020 15:56:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896703
Page 243 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 15:57:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Iron Deficiency AnemiaTranscription Error
Sep-01-2020 15:57:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-01-2020 15:56:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Herniated Lumbar DiscsInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-01-2020 15:57:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Transcription Error
Sep-01-2020 15:56:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-01-2020 15:56:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-01-2020 15:58:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:9
Medical History T
erm:EczemaInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0896704
Page 244 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/1
998
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:58:37
(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
Sep-01-2020 15:58:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EczemaInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-01-2020 15:58:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-01-2020 15:58:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Sep-01-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:10
Medical History T
erm:Allergic Rhin
itis
Start Date: UNK/UNK/2
010Initial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896705
Page 245 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: YES
1.j Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:58:56
(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
Sep-01-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Allergic RhinitisInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-01-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-01-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Sep-01-2020 15:59:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:11
Medical History
Term:Septoplasty
Start Date: UNK/UNK/201
7Initial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896706
Page 246 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/
2017
1.k Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:59:20
(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
Sep-01-2020 15:59:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SeptoplastyInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-01-2020 15:59:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-01-2020 15:59:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.l
Date Location User Value Reason
Sep-01-2020 15:59:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:12Initial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896707
Page 247 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History
Term:Laminoectomy
Start Date: Aug/UNK/201
3
Ongoing: NO
End Date:
Aug/UNK/2
013
1.l Line/MH Number:
Date Location User Value Reason
Sep-01-2020 15:59:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 15:59:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LaminoectomyInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-01-2020 15:59:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/UNK/2013Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-01-2020 15:59:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/UNK/2013Initial Entry
1.m
Date Location User Value Reason
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896708
Page 248 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-01-2020 16:00:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:13
Medical Histo
ry Term:Cosmetic Breast
Reduction
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/20
05Initial Entry
1.m Line/MH Number:
Date Location User Value Reason
Sep-01-2020 16:00:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 16:00:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cosmetic Breast ReductionInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-01-2020 16:00:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-01-2020 16:00:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.n
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896709
Page 249 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-01-2020 16:00:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:14
Medical History
Term:Breast Augment
ation
Start Date: UNK/UNK/201
6
Ongoing: NO
End Date:
UNK/UNK/
2016Initial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896710
Page 250 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.n Line/MH Number:
Date Location User Value Reason
Sep-01-2020 16:00:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 16:00:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Breast AugmentationInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-01-2020 16:00:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-01-2020 16:00:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896711
Page 251 of 372
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020 16:01:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-01-2020 16:01:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
141.7Initial Entry
3. Unit:
Date Location User Value Reason
Sep-01-2020 16:01:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-01-2020 16:01:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
66.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-01-2020 16:01:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-01-2020 16:01:44
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.9Initial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0896712
Page 252 of 372
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-01-2020 16:01:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.5
Temperature Unit: F
Temperature Location:: EARInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-01-2020 16:01:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-01-2020 16:01:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.5Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-01-2020 16:01:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-01-2020 16:01:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EARInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0896713
Page 253 of 372
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-01-2020 16:01:56
(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-01-2020 16:01:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-01-2020 16:01:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-01-2020 16:01:56
(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-01-2020 16:01:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896714
Page 254 of 372
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-01-2020 16:01:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-01-2020 16:01:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-01-2020 16:01:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-01-2020 16:01:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896715
Page 255 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-01-2020 16:02:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-01-2020 16:02:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
75488Initial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896716
Page 256 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 16:04:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 16:04:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 16:23:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-01-2020 16:04:13
(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-01-2020 16:04:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 16:23:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP98BXInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896717
Page 257 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 16:23:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP98BXInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020 16:23:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP98BYInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020 16:23:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP98BYInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020 16:23:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP98BZInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020 16:23:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP98BZInitial Entry
5.d
Date Location User Value Reason
Sep-01-2020 16:23:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRMD1Initial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0896718
Page 258 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Sep-01-2020 16:23:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRMD1Initial Entry
5.e
Date Location User Value Reason
Sep-01-2020 16:23:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRMD2Initial Entry
5.e Sample ID
Date Location User Value Reason
Sep-01-2020 16:23:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRMD2Initial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896719
Page 259 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 16:24:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 16:24:02
(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-01-2020 16:24:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-01-2020 16:24:02
(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-01-2020 16:24:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 16:24:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM864MInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896720
Page 260 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 16:24:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM864MInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896721
Page 261 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-01-2020 16:05:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020 16:05:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020 16:05:09
(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-01-2020 16:05:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020 14:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020 16:05:09
(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-01-2020 16:05:09
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896722
Page 262 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-01-2020 16:05:09
(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-01-2020 16:05:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-01-2020 16:05:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896723
Page 263 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191145 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-01-2020 16:05:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3e2d\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896724
Page 264 of 372
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subjec
…[truncated]