Document text
Page 1 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906413
Page 2 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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/2/2020
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906414
Page 3 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10391075]
2.Birth Date: /1936
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:
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906415
Page 4 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906416
Page 5 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906417
Page 6 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906418
Page 7 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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:[hearing problems]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cataract surgery]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergic rhinitis]
Start Date: UNK/UNK/1970
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[stent placement]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906419
Page 8 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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:[high blood pressure]
Start Date: UNK/UNK/1990
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hyperlipidemia]
Start Date: UNK/UNK/1980
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[abdominal hernia]
Start Date: UNK/UNK/2018
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[irritable bowel syndrome]
Start Date: UNK/UNK/2017
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypothyroidism]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906420
Page 9 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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:[type II diabetes]
Start Date: UNK/UNK/2018
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteoarthritis]
Start Date: UNK/UNK/2018
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[basal cell skin cancer]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety]
Start Date: UNK/UNK/2010
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[vitamin d deficiency]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906421
Page 10 of 334
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[colonoscopy]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[skin biopsy]
Start Date: UNK/UNK/1980
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[congestive heart failure]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906422
Page 11 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [83.9]
3.Unit: kg
4.Height: [158.1]
5.Unit: cm
6.Body Mass Index: [33.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906423
Page 12 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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/2/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906424
Page 13 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [250082]
3.Randomization Group: [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906425
Page 14 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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/2/2020
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 [BL9WYX]
5.bSample ID [BL9WYY]
5.cSample ID [BN5TKG]
5.dSample ID [BN5TKH]
5.eSample ID [BN5TKJ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906426
Page 15 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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/2/2020
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 [BN5T2C]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906427
Page 16 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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/2/2020 13:56
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906428
Page 17 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906429
Page 18 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906430
Page 19 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906431
Page 20 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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:
Not Done: NOT DONE
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906432
Page 21 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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 [BN5T75]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906433
Page 22 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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 12:18
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906434
Page 23 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906435
Page 24 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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 [BRV1DS]
5.bSample ID [BRV1DT]
5.cSample ID [BPW2YS]
5.dSample ID [BPW2YT]
5.eSample ID [BPW2YV]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906436
Page 25 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906437
Page 26 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/28/2021
2.Date of First Symptom Started: Jan/22/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/26/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
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
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906438
Page 27 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906439
Page 28 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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/23/202
1 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906440
Page 29 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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/23/2021
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: [NALT Unknown] Comments
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906441
Page 30 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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:[Patient swab was collected in office by investigator]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906442
Page 31 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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:
Jan/28/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMFNG]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906443
Page 32 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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: YES
Number of Visits or Contacts:
[1]
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?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906444
Page 33 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Jan/23/2021 NO
Discharge Date:
Jan/26/2021
Repeating Pages
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906445
Page 34 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Jan/23/2021
4.Ongoing? NO
Discharge Date:
Jan/26/2021
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906446
Page 35 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906447
Page 36 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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 Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906448
Page 37 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[exacerbation of congestive heart failure]
Date of Diagnosis:
Jan/23/2021
3.Toxicity Grade: 3
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906449
Page 38 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906450
Page 39 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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 Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906451
Page 40 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Nam
eCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.CLINICAL CH
EMISTRY Heart Hospita
l of Austin Jan/23/20
21 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
329 C Reactive Protein
_PX329 [ ]
30 Alanine Aminotran
sferase_PX30 [ ]
28 Aspartate Aminotra
nsferase_PX28 [ ]
35 Alkaline Phosphata
se_PX35 86
21 Bilirubin_PX21 .5
47 Blood Urea Nitroge
n_PX47 21
48 Creatinine_PX48 .9 Repeating
Pages
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906452
Page 41 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Heart Hospital of Austin]
3.Collection Date: Jan/23/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906453
Page 42 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [86]
Not Done:
LNMT Low
[30]
High
[100]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [.5]
Not Done:
LNMT Low
[.2]
High
[1.0]
Unit
mg/dL
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906454
Page 43 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [21]
Not Done:
LNMT Low
[7]
High
[18]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [.9]
Not Done:
LNMT Low
[.6]
High
[1.3]
Unit
mg/dL
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906455
Page 44 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1.HEMATOLO
GY Heart Hospital of
Austin Jan/23/202
1 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
1 Hemoglobin_
PX1 11
2 Hematocrit_P
X2 32.5
3 Erythrocytes
_PX3 [ ]
5 Platelets_PX
5 244
7 Leukocytes_
PX7 [ ]
608 Neutrophils_
PX608 5.8
609 Eosinophils_
PX609 .3
612 Monocytes_P
X612 1.1
610 Basophils_P
X610 0
611 Lymphocytes
_PX611 2.2 Repeating
Pages
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906456
Page 45 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Heart Hospital of Austin]
3.Collection Date: Jan/23/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [11]
Not Done:
LNMT Low
[12]
High
[16]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [32.5]
Not Done:
LNMT Low
[37]
High
[47]
Unit
%
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906457
Page 46 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [244]
Not Done:
LNMT Low
[130]
High
[400]
Unit
10^6/cu mm
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906458
Page 47 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [5.8]
Not Done:
LNMT Low
[2.1]
High
[7.0]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [.3]
Not Done:
LNMT Low
[0]
High
[.3]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [1.1]
Not Done:
LNMT Low
[.3]
High
[1.3]
Unit
10^3/uL
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906459
Page 48 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0]
Not Done:
LNMT Low
[0]
High
[.1]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [2.2]
Not Done:
LNMT Low
[1.0]
High
[4.9]
Unit
10^3/uL
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906460
Page 49 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Jan/23/2021 Record Identifier: Systolic: Diastolic:
1 143 54 Repeating Pages
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906461
Page 50 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/23/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [143]
Diastolic: [54]
Respiratory Rate in
respirations/minute:[15]
Heart Rate in beats/minute: [64]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906462
Page 51 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Jan/23/2021 Record Identifier: Oxygen Saturation
1 94.0 Repeating Pages
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906463
Page 52 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/23/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [94.0]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906464
Page 53 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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 Done Not Done Not Done Repeating Pages
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906465
Page 54 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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 Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906466
Page 55 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906467
Page 56 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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 Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done 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 Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906468
Page 57 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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.Jan/23/2021 CHEST X-RAY NORMAL Repeating Pages
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906469
Page 58 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/23/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: NORMAL
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906470
Page 59 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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:
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906471
Page 60 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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 [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906472
Page 61 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906473
Page 62 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906474
Page 63 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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: [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906475
Page 64 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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: [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906476
Page 65 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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:
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906477
Page 66 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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 [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906478
Page 67 of 334
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1.ADVERSE E
VENT 1 panic attack Sep/5/2020 12:0
0 NO
End Date Time:
Sep/5/2020 12:05
Repeating
Pages
2.ADVERSE E
VENT 2 conjunctivitis Sep/9/2020 UN
K:UNK NO
End Date Time:
Oct/30/2020 13:00
Repeating
Pages
3.ADVERSE E
VENT 3 melanoma, left ankle Nov/13/2020 00:
00 NO
End Date Time:
Dec/23/2020 UNK:UN
K
Repeating
Pages
4.ADVERSE E
VENT 4 exacerbation of congestive
heart failure Jan/22/2021 UN
K:UNK NO
End Date Time:
Jan/26/2021 UNK:UN
K
Repeating
Pages
5.ADVERSE E
VENT 5 cellulitis- left ankle Jan/23/2021 UN
K:UNK NO
End Date Time:
Mar/2/2021 UNK:UN
K
Repeating
Pages
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906479
Page 68 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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)[panic attack]
4.Start Date Time: Sep/5/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/5/2020 12:05
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Patient has history of anxiety.]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906480
Page 69 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906481
Page 70 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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)[conjunctivitis]
4.Start Date Time: Sep/9/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/30/2020 13:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[infection]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906482
Page 71 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906483
Page 72 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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)[melanoma, left ankle]
4.Start Date Time: Nov/13/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/23/2020 UNK:UNK
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
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906484
Page 73 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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:
[SUN EXPOSURE]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020481646]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906485
Page 74 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[exacerbation of congestive heart failure]
4.Start Date Time: Jan/22/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/26/2021 UNK:UNK
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?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906486
Page 75 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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:
[existing medical history]
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?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021082203]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906487
Page 76 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[cellulitis- left ankle]
4.Start Date Time: Jan/23/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/2/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[surgical site infection]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906488
Page 77 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906489
Page 78 of 334
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906490
Page 79 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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[ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906491
Page 80 of 334
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906492
Page 81 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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: //
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906493
Page 82 of 334
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906494
Page 83 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906495
Page 84 of 334
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906496
Page 85 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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?
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906497
Page 86 of 334
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906498
Page 87 of 334
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906499
Page 88 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906500
Page 89 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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:
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906501
Page 90 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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:
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906502
Page 91 of 334
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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?
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906503
Page 92 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906504
Page 93 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906505
Page 94 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906506
Page 95 of 334
***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, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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 per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906507
Page 96 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906508
Page 97 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/6/2021
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906509
Page 98 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906510
Page 99 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/6/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906511
Page 100 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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: Jan/6/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906512
Page 101 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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:
Jan/6/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJBR7]
5.bSample ID [BS6HN9]
5.cSample ID [BRV14R]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906513
Page 102 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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:
Jan/6/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJB9R]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906514
Page 103 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/6/2021 14:42
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906515
Page 104 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/29/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906516
Page 105 of 334
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906517
Page 106 of 334
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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: [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906518
Page 107 of 334
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906519
Page 108 of 334
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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: Jan/28/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906520
Page 109 of 334
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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:[see nasal swab sample on cov illness visit CRF]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906521
Page 110 of 334
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/28/2021 13:16
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906522
Page 111 of 334
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906523
Page 112 of 334
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/25/2021
3.Comments: [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906524
Page 113 of 334
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906525
Page 114 of 334
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906526
Page 115 of 334
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906527
Page 116 of 334
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906528
Page 117 of 334
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/25/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906529
Page 118 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906530
Page 119 of 334
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906531
Page 120 of 334
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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
Name Signature
MeaningDate Type Action
Gretchen Crook Approved Mar-11-2021 12:35:22 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GretchenCrook, 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.
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906532
Page 121 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-02-2020 15:18:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906533
Page 122 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Feb-01-2021 12:31:52 (UTC-06:00) Central
Time (US & Canada)
9Jan-29-2021 17:31:19 (UTC-06:00) Central Time
(US & Canada)Unknown
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906534
Page 123 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-29-2021 17:52:51 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906535
Page 124 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-29-2021 17:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906536
Page 125 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-29-2021 17:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906537
Page 126 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-29-2021 17:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906538
Page 127 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-29-2021 17:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906539
Page 128 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Jan-29-2021 17:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906540
Page 129 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Jan-29-2021 17:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906541
Page 130 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-29-2021 17:53:02 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906542
Page 131 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-29-2021 17:53:02 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906543
Page 132 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-29-2021 17:53:02 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906544
Page 133 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-29-2021 17:53:02 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906545
Page 134 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-29-2021 17:53:02 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906546
Page 135 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-29-2021 17:53:14 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906547
Page 136 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-29-2021 17:53:14 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906548
Page 137 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-29-2021 17:53:14 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906549
Page 138 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-29-2021 17:53:14 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906550
Page 139 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-29-2021 17:53:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906551
Page 140 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-29-2021 17:53:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906552
Page 141 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-29-2021 17:53:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906553
Page 142 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-29-2021 17:53:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906554
Page 143 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-29-2021 17:53:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906555
Page 144 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Jan-29-2021 17:53:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906556
Page 145 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Jan-29-2021 17:53:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906557
Page 146 of 334
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-06-2021 16:47:30 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906558
Page 147 of 334
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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
Name Signature
MeaningDate Type Action
Gretchen Crook Approved Mar-11-2021 12:35:22 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GretchenCrook, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-01-2021 16:33:18 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gretchen Crook Approved Feb-01-2021 16:10:54 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GretchenCrook, 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-27-2021 12:06:24 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906559
Page 148 of 334
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Gretchen Crook Approved Jan-21-2021 19:46:28 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GretchenCrook, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-04-2020 15:12:37 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gretchen Crook Approved Oct-26-2020 16:32:42 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GretchenCrook, 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.
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906560
Page 149 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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-02-2020 15:16:59
(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-02-2020 15:16:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906561
Page 150 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-02-2020 15:17:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/2/2020Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906562
Page 151 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-02-2020 15:16:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10391075Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-02-2020 15:16:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1936Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-02-2020 15:17:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-02-2020 15:17:20
(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-02-2020 15:17:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906563
Page 152 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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-02-2020 15:17:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906564
Page 153 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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-02-2020 15:18:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-02-2020 15:18:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-02-2020 15:18:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906565
Page 154 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-02-2020 15:25:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:hearing probl
ems
Start Date: UNK/UNK/2
017
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:25:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 15:25:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hearing problemsInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-02-2020 15:25:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-02-2020 15:25:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906566
Page 155 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b
Date Location User Value Reason
Sep-02-2020 15:25:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:cataract surgery
Start Date: UNK/UNK/201
7
Ongoing: NO
End Date:
UNK/UNK/
2017Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906567
Page 156 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:25:51
(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-02-2020 15:25:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cataract surgeryInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-02-2020 15:25:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-02-2020 15:25:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.c
Date Location User Value Reason
Sep-02-2020 15:26:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History T
erm:allergic rhiniti
s
Start Date: UNK/UNK/1
970
Ongoing: YESInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906568
Page 157 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:26:53
(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-02-2020 15:26:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
allergic rhinitisInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-02-2020 15:26:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1970Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-02-2020 15:26:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-02-2020 15:27:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:stent placement
Start Date: UNK/UNK/199
0
Ongoing: NO
End Date:
UNK/UNK/
1990Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906569
Page 158 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:27:31
(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-07-2020 21:07:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-04-2020 09:32:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Data is not in
subject record
Sep-03-2020 19:41:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Stent
Placement: Please
can you update to
indicate the location
of this medhx?
Thanks
Sep-02-2020 15:27:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
stent placementInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-02-2020 15:27:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-02-2020 15:27:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906570
Page 159 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e
Date Location User Value Reason
Sep-02-2020 15:27:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:high blood pre
ssure
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:27:55
(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-02-2020 15:27:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
high blood pressureInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-02-2020 15:27:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-02-2020 15:27:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906571
Page 160 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-02-2020 15:30:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:hyperlipidemi
a
Start Date: UNK/UNK/1
980
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:30:03
(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-02-2020 15:30:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hyperlipidemiaInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-02-2020 15:30:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-02-2020 15:30:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-02-2020 15:30:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number 7Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906572
Page 161 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
:
Medical History T
erm:abdominal he
rnia
Start Date: UNK/UNK/2
018
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:30:22
(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-02-2020 15:30:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
abdominal herniaInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-02-2020 15:30:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-02-2020 15:30:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-02-2020 15:30:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906573
Page 162 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical Histor
y Term:irritable bowel s
yndrome
Start Date: UNK/UNK/2017
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:30:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 15:30:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
irritable bowel syndromeInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-02-2020 15:30:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-02-2020 15:30:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-02-2020 15:31:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:9
Medical History T
erm:hypothyroidis
mInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906574
Page 163 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/2
015
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:31:12
(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-02-2020 15:31:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hypothyroidismInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-02-2020 15:31:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-02-2020 15:31:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Sep-02-2020 15:31:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History T
erm:type II diabet
es
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906575
Page 164 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.j Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:31:34
(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-02-2020 15:31:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
type II diabetesInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-02-2020 15:31:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-02-2020 15:31:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Sep-02-2020 15:32:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 11
Medical History T
erm:osteoarthritis
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906576
Page 165 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.k Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:32:27
(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-02-2020 15:32:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
osteoarthritisInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-02-2020 15:32:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-02-2020 15:32:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Sep-02-2020 15:33:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12
Medical History
Term:basal cell skin c
ancer
Start Date: UNK/UNK/201
9
Ongoing: NO
End Date:
UNK/UNK/
2019Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906577
Page 166 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.l Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:33:02
(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-07-2020 03:59:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-04-2020 09:32:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Data is not in
subject record
Sep-03-2020 20:02:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Please
could you also
provide the location
(Eg; neck, Arm,
Leg) of the Basal
Cell Carcinoma
Sep-02-2020 15:33:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
basal cell skin cancerInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-02-2020 15:33:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-02-2020 15:33:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906578
Page 167 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.m
Date Location User Value Reason
Sep-02-2020 15:33:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 13
Medical History T
erm:anxiety
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
1.m Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:33:23
(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-02-2020 15:33:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
anxietyInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-02-2020 15:33:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-02-2020 15:33:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906579
Page 168 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-02-2020 15:34:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:14
Medical History
Term:vitamin d defic
iency
Start Date: UNK/UNK/20
16
Ongoing: YESInitial Entry
1.n Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:34:10
(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-02-2020 15:34:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
vitamin d deficiencyInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-02-2020 15:34:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-02-2020 15:34:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Sep-02-2020 15:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe 15Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906580
Page 169 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
r:
Medical History
Term:colonoscopy
Start Date: UNK/UNK/201
7
Ongoing: NO
End Date:
UNK/UNK/
2017
1.o Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 15:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
colonoscopyInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-02-2020 15:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-02-2020 15:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.p
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906581
Page 170 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-02-2020 15:35:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 16
Medical History T
erm:skin biopsy
Start Date: UNK/UNK/1
980
Ongoing: YESInitial Entry
1.p Line/MH Number:
Date Location User Value Reason
Sep-02-2020 15:35:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 15:35:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
skin biopsyInitial Entry
1.p Start Date:
Date Location User Value Reason
Sep-02-2020 15:35:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.p Ongoing:
Date Location User Value Reason
Sep-02-2020 15:35:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Jan-28-2021 10:58:30
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb 17Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906582
Page 171 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) er:
Medical History
Term:congestive heart
failure
Start Date: UNK/UNK/201
9
Ongoing: YES
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906583
Page 172 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.q Line/MH Number:
Date Location User Value Reason
Jan-28-2021 10:58:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-02-2021 04:52:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed AS per site
confirmation
Feb-01-2021 13:18:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered all known medical
history items have
been added at this
time
Feb-01-2021 09:42:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN:
Congestive heart
failure was added to
medical history.
Please review
medical history to
ensure it is complete
and if there was an
additional
cardiovascular
conditions that
should be added,
please update.
Jan-28-2021 10:58:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
congestive heart failureInitial Entry
1.q Start Date:
Date Location User Value Reason
Jan-28-2021 10:58:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.q Ongoing:
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906584
Page 173 of 334
***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, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Jan-28-2021 10:58:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906585
Page 174 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020 15:20:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-02-2020 15:20:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
83.9Initial Entry
3. Unit:
Date Location User Value Reason
Sep-02-2020 15:20:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-02-2020 15:20:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
158.1Initial Entry
5. Unit:
Date Location User Value Reason
Sep-02-2020 15:20:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-02-2020 15:20:08
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
33.6Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906586
Page 175 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-02-2020 15:20:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.8
Temperature Unit
:C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-02-2020 15:20:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-02-2020 15:20:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-02-2020 15:20:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-02-2020 15:20:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906587
Page 176 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-02-2020 15:20:44
(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-02-2020 15:20:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-02-2020 15:20:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-02-2020 15:20:44
(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-02-2020 15:20:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-02-2020 15:20:44 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906588
Page 177 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)(autocalc) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Sep-02-2020 15:20:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-02-2020 15:20:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-02-2020 15:20:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906589
Page 178 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-02-2020 15:22:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-07-2020 06:17:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Data updated per
query
Sep-04-2020 12:50:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Sep-04-2020 12:50:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
250082Changed
Information
Sep-04-2020 03:59:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened IVRS
Reconciliation:
Randomization
number recorded at
impala 250082 is
not matching with
number recorded at
inform. Please
review and update
data as appropriate.
Else clarify. Thank
you.
Sep-02-2020 15:22:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
25082Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906590
Page 179 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 15:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 15:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 15:39:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 15:22:16
(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-02-2020 15:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020 15:39:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9WYXInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906591
Page 180 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 15:39:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BL9WYXInitial Entry
5.b
Date Location User Value Reason
Sep-02-2020 15:39:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9WYYInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-02-2020 15:39:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BL9WYYInitial Entry
5.c
Date Location User Value Reason
Sep-02-2020 15:47:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5TKGInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-02-2020 15:47:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN5TKGInitial Entry
5.d
Date Location User Value Reason
Sep-02-2020 15:47:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5TKHInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906592
Page 181 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Sep-02-2020 15:47:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN5TKHInitial Entry
5.e
Date Location User Value Reason
Sep-02-2020 15:47:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5TKJInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-02-2020 15:47:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN5TKJInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906593
Page 182 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 15:23:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 15:23:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 15:42:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 15:23:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-02-2020 15:23:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020 15:42:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5T2CInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906594
Page 183 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 15:42:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN5T2CInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906595
Page 184 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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-02-2020 15:23:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020 15:23:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020 15:23:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-02-2020 15:23:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020 13:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020 15:23:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-02-2020 15:23:49
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906596
Page 185 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-02-2020 15:23:49
(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-02-2020 15:23:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-02-2020 15:23:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906597
Page 186 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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-02-2020 15:23:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906598
Page 187 of 334
***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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-23-2020 13:30:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906599
Page 188 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020 13:30:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-23-2020 13:30:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.6
Temperature Unit
:C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-23-2020 13:30:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-23-2020 13:30:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-23-2020 13:30:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906600
Page 189 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.a Temperature Location:
Date Location User Value Reason
Sep-23-2020 13:30:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906601
Page 190 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-23-2020 13:32:22
(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-23-2020 13:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-23-2020 13:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-23-2020 13:32:22
(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-23-2020 13:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-23-2020 13:32:22 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906602
Page 191 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)(autocalc) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Sep-23-2020 13:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-23-2020 13:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-23-2020 13:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906603
Page 192 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 13:33:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 13:33:45
(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-23-2020 13:58:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 13:33:45
(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-23-2020 13:33:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020 13:58:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5T75Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906604
Page 193 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-23-2020 13:58:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN5T75Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906605
Page 194 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 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-23-2020 13:34:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020 13:34:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020 13:34:12
(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-23-2020 13:34:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020 12:18Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020 13:34:12
(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-23-2020 13:34:12
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906606
Page 195 of 334
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-23-2020 13:34:12
(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-23-2020 13:34:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-23-2020 13:34:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906607
Page 196 of 334
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-03-2020 06:36:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Issue resolved, no
issue in current
holds report
Oct-28-2020 08:19:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate Awaiting update in
HOLDS report
Oct-27-2020 13:57:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Swab was for
subject 10391175-
updated SCF was
sent to Pfizer lab on
22OCT2020
Oct-27-2020 07:44:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened HOLDS: Nasal self-
swab barcode
CV06430 was
received by the lab
for COVID_A.
Please review and
update accordingly
or submit an
updated SCF.
Oct-22-2020 11:51:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/22/2020Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906608
Page 197 of 334
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 11:52:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 11:52:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 12:20:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 11:52:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-22-2020 11:52:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020 12:20:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRV1DSInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906609
Page 198 of 334
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 12:20:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRV1DSInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020 12:20:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRV1DTInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020 12:20:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRV1DTInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020 12:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW2YSInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020 12:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPW2YSInitial Entry
5.d
Date Location User Value Reason
Oct-22-2020 12:20:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW2YTInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906610
Page 199 of 334
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Oct-22-2020 12:20:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPW2YTInitial Entry
5.e
Date Location User Value Reason
Oct-22-2020 12:20:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW2YVInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-22-2020 12:20:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPW2YVInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906611
Page 200 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-10-2021 00:11:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed this will be checked
post BLA
Mar-09-2021 15:42:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered patient has been
contacted and
scheduled to come
in .
Mar-08-2021 00:31:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Reissued:Opened PDQ RQ1:Thank
you for the response,
however Please
confirm whether
subject was
contacted and
accordingly, enter
corresponding
CONVA visit else
provide planned
CONVA visit date.
Mar-05-2021 10:39:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered Visit will be
conducted OOW
Mar-05-2021 05:58:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened PDQ: Convalescent
visit is missing and
35+ days (36) have
passed since COVID
Illness Visit. If visit
occurred record data
as a matching
CONVA visit; if
visit did not occur
attempt to schedule
visit even if OOW
and obtain the
CONVA sample else
clarify.
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906612
Page 201 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-02-2021 13:45:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 3: Closed Response satisfies
query
Feb-01-2021 13:18:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered medical records
were obtained and
all available
information was
entered.
Feb-01-2021 10:02:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 3: Opened Clin: It was stated in
the SAE report
#2021082203 that
the subject was
hospitalized. Please
obtain subject
medical records and
update as
appropriate the CRF
forms (COVID
TEST, ILL
SEVERE, LAB
CHEM/HME,
VITAL COV,
PULSE OX,
OXYGEN,
VASOPRESS,
IMAGING)
Jan-29-2021 17:33:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-29-2021 17:30:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Jan-29-2021 17:30:09 ACV0PFEINFP6000 auto query Query 1: Candidate Date of Visit is
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0906613
Page 202 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)(autoquery) completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Jan-29-2021 17:30:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/28/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-29-2021 17:30:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906614
Page 203 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/28/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/22/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolved
:
Jan/26/2021Initial Entry
4.a
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906615
Page 204 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:YESInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906616
Page 205 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.c Symptoms:
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORT
NESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAINInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906617
Page 206 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptom
Present:NO
4.e Symptoms:
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW LOSS OF TA
STE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906618
Page 207 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906619
Page 208 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.i
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-29-2021 17:30:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906620
Page 209 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Jan-29-2021 17:31:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906621
Page 210 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Feb-02-2021 14:39:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 1: Closed Response satisfies
query
Feb-01-2021 12:32:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered updated
Feb-01-2021 09:00:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 1: Opened Clin: If the Trade
Name is not is not
available, and if it is
not known whether
the test was
performed in a
CLIA-certified
laboratory or in a
laboratory
accredited by the
ISO15189 standard,
please enter “NALT
Unknown”
Jan-29-2021 17:31:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/23/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-29-2021 17:31:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-29-2021 17:31:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0906622
Page 211 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4. Assay Code and Description:
Date Location User Value Reason
Jan-29-2021 17:31:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Jan-29-2021 17:31:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-03-2021 04:23:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-02-2021 12:50:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Feb-02-2021 03:44:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Per CCG
section 8.31.7 if
trade name is
OTHER kindly,
consider updating
Trade Name Other,
Specify as NALT
Unknown. Kindly
verify and consider
updating data as
appropriate or else
clarify. Thank you.
Feb-01-2021 12:32:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto Query
Feb-01-2021 00:33:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Per CCG
section 8.31.7 if
trade name is
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b)
(4),
(b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0906623
Page 212 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
OTHER kindly,
consider updating
Trade Name Other,
Specify as NALT
Unknown. Kindly
verify and consider
updating data as
appropriate or else
clarify. Thank you.
Jan-29-2021 17:32:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered test name unknown
Jan-29-2021 17:31:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Trade Name is
Other, however
Trade Name Other,
Specify is not
completed. Please
update.
Jan-29-2021 17:31:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Jan-29-2021 17:31:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Feb-01-2021 12:32:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NALT UnknownInitial Entry
Feb-01-2021 12:31:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-29-2021 17:31:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UnknownInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (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-2021-5683-0906624
Page 213 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-29-2021 17:32:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 17:32:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-29-2021 17:32:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-29-2021 17:32:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Patient swab was collected in offi
ce by investigatorInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906625
Page 214 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-29-2021 17:33:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 17:33:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-29-2021 17:33:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-29-2021 17:33:49
(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.
Jan-29-2021 17:33:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/28/2021Initial Entry
5.a
Date Location User Value Reason
Jan-29-2021 17:33:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRMFNGInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906626
Page 215 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Jan-29-2021 17:33:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRMFNGInitial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906627
Page 216 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Jan-29-2021 17:34:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Jan-29-2021 17:34:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-29-2021 17:34:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Jan-29-2021 17:34:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:EMERGENCY
ROOM
Occurrence of
Visits or Conta
cts:YES
Number of Vis
its or Contact
s:
1Initial Entry
090177e196ae3e5c\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906628
Page 217 of 334
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke
Subject No: 10391075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Jan-29-2021 17:34:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP
…[truncated]