Document text
Page 1 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829721
Page 2 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/11/2020
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829722
Page 3 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Demography
1.Subject ID [12481120]
2.Birth Date: /1945
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829723
Page 4 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/11/2020
2.Erroneous Visit
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829724
Page 5 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829725
Page 6 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829726
Page 7 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Stroke]
Start Date: UNK/UNK/2014
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Arthritis]
Start Date: UNK/UNK/2015
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Penicillin/Sulfa Hives]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829727
Page 8 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Vital Signs
1.Date: Sep/11/2020
2.Weight: [119.3]
3.Unit: kg
4.Height: [180.0]
5.Unit: cm
6.Body Mass Index: [36.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829728
Page 9 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/11/2020
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
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829729
Page 10 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/11/2020
2.Randomization Number: [256789]
3.Randomization Group: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829730
Page 11 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/11/2020
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 [BP8LC4]
5.bSample ID [BMNXY1]
5.cSample ID [BMNXY2]
5.dSample ID [BMNXY3]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829731
Page 12 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/11/2020
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 [BP8LC0]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829732
Page 13 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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/11/2020 15:41
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829733
Page 14 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829734
Page 15 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829735
Page 16 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Vital Signs
1.Date: Oct/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829736
Page 17 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/21/2020
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
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829737
Page 18 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
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 [BPW1GB]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829738
Page 19 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Oct/1/2020
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESS
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/21/2020 13:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829739
Page 20 of 278
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/18/2020
2.Erroneous Visit
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829740
Page 21 of 278
***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, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/18/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRFZ45]
5.bSample ID [BS7YY3]
5.cSample ID [BS7YY4]
5.dSample ID [BS7YY5]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829741
Page 22 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829742
Page 23 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/2/2020
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
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? NO
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
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829743
Page 24 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829744
Page 25 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Sep/27/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829745
Page 26 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/27/2020
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: POSITIVE
8.Comments/Findings/Details: [Subject was tested while in hospital for SAE; subject denies ever having COVID
symptoms]
9.Trade Name Other, Specify: [NALT unknown]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829746
Page 27 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Subject was hospitalized for SAE; COVID test performed there.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829747
Page 28 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Subject was hospitalized for SAE; COVID test performed there.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829748
Page 29 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829749
Page 30 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829750
Page 31 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829751
Page 32 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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?NO
3.Toxicity Grade: 0
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829752
Page 33 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829753
Page 34 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829754
Page 35 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829755
Page 36 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829756
Page 37 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829757
Page 38 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829758
Page 39 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829759
Page 40 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829760
Page 41 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829761
Page 42 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829762
Page 43 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829763
Page 44 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829764
Page 45 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829765
Page 46 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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.Start Date: //
6.Ongoing?
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829766
Page 47 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829767
Page 48 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829768
Page 49 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829769
Page 50 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Mar/8/2021
2.Date of First Symptom Started: Jan/21/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/21/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? 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? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829770
Page 51 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829771
Page 52 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descrip
tionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829772
Page 53 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829773
Page 54 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB_SELF Comments
3.Sample Collected? NO Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Sxs resolved more than 4 days] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829774
Page 55 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? NO Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Sxs resolved more than 4 days] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829775
Page 56 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829776
Page 57 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829777
Page 58 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829778
Page 59 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829779
Page 60 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829780
Page 61 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829781
Page 62 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829782
Page 63 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829783
Page 64 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829784
Page 65 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829785
Page 66 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829786
Page 67 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829787
Page 68 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829788
Page 69 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829789
Page 70 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829790
Page 71 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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.Start Date: //
6.Ongoing?
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829791
Page 72 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829792
Page 73 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829793
Page 74 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829794
Page 75 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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 [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829795
Page 76 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829796
Page 77 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Unplanned Assessments
1.Assessments
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829797
Page 78 of 278
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/18/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829798
Page 79 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829799
Page 80 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829800
Page 81 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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 [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829801
Page 82 of 278
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
# CategoryAE Identi
fierAdverse E
ventStart DateIs the Adverse Event Still
OngoingForm Instanc
e
1. ADVERSE E
VENT 1 Mild Strok
e Sep/23/2020 UN
K:UNK YES Repeating
Pages
2. DELETED ADVERSE E
VENT 2 Diarrhea Jan/21/2021 UNK
:UNK NO
End Date Time:
Jan/21/2021 UNK:UNK
Repeating
Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829802
Page 83 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1] Comments
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Mild Stroke]
4.Start Date Time: Sep/23/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
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
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
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829803
Page 84 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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:
[Atherosclerotic cardiovascular disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020381724]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829804
Page 85 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Diarrhea]
4.Start Date Time: Jan/21/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/21/2021 UNK:UNK
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:
[Subject stated that diarrhea was due to eating burger and milkshake ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829805
Page 86 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?: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[ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829806
Page 87 of 278
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829807
Page 88 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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[ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829808
Page 89 of 278
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829809
Page 90 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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: //
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829810
Page 91 of 278
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829811
Page 92 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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?
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829812
Page 93 of 278
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829813
Page 94 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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?
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829814
Page 95 of 278
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829815
Page 96 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829816
Page 97 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829817
Page 98 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829818
Page 99 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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:
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829819
Page 100 of 278
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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?
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829820
Page 101 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829821
Page 102 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829822
Page 103 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829823
Page 104 of 278
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829824
Page 105 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/15/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829825
Page 106 of 278
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829826
Page 107 of 278
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829827
Page 108 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829828
Page 109 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/15/2021
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829829
Page 110 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829830
Page 111 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/15/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829831
Page 112 of 278
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/15/2021
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
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829832
Page 113 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/15/2021
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 [BRFYP6]
5.bSample ID [BSGZY4]
5.cSample ID [BSGZY5]
5.dSample ID [BSGZY6]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829833
Page 114 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/15/2021
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 [BRFYP4]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829834
Page 115 of 278
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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/15/2021 12:02
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829835
Page 116 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829836
Page 117 of 278
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/5/2021
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
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829837
Page 118 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/5/2021
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 [BRFYSM]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829838
Page 119 of 278
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
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: Feb/5/2021 13:01
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829839
Page 120 of 278
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829840
Page 121 of 278
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829841
Page 122 of 278
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829842
Page 123 of 278
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829843
Page 124 of 278
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829844
Page 125 of 278
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829845
Page 126 of 278
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829846
Page 127 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/18/2020
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829847
Page 128 of 278
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829848
Page 129 of 278
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829849
Page 130 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
FormSep-13-2020 14:13:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829850
Page 131 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
2Nov-06-2020 11:30:15 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829851
Page 132 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
3Nov-06-2020 11:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829852
Page 133 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
FormMar-08-2021 12:19:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829853
Page 134 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
1Mar-08-2021 12:19:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829854
Page 135 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
2Mar-08-2021 12:19:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829855
Page 136 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
3Mar-08-2021 12:19:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829856
Page 137 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
4Mar-08-2021 12:19:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829857
Page 138 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
5Mar-08-2021 12:19:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829858
Page 139 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
6Mar-08-2021 12:19:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829859
Page 140 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
7Mar-08-2021 12:19:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829860
Page 141 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
8Mar-08-2021 12:19:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829861
Page 142 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
9Mar-08-2021 12:19:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829862
Page 143 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
FormMar-09-2021 10:29:53 (UTC-05:00) Eastern
Time (US & Canada)
FormMar-08-2021 12:20:05 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829863
Page 144 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
1Mar-09-2021 10:29:53 (UTC-05:00) Eastern
Time (US & Canada)
1Mar-08-2021 12:20:05 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829864
Page 145 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
2Mar-09-2021 10:29:53 (UTC-05:00) Eastern
Time (US & Canada)
2Mar-08-2021 12:20:05 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829865
Page 146 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
3Mar-09-2021 10:29:53 (UTC-05:00) Eastern
Time (US & Canada)
3Mar-08-2021 12:20:05 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829866
Page 147 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
4Mar-09-2021 10:29:53 (UTC-05:00) Eastern
Time (US & Canada)
4Mar-08-2021 12:20:05 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829867
Page 148 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
FormMar-09-2021 10:28:20 (UTC-05:00) Eastern
Time (US & Canada)
FormMar-08-2021 12:24:26 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829868
Page 149 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
1Mar-09-2021 10:28:20 (UTC-05:00) Eastern
Time (US & Canada)
1Mar-08-2021 12:24:26 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829869
Page 150 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
2Mar-09-2021 10:28:20 (UTC-05:00) Eastern
Time (US & Canada)
2Mar-08-2021 12:24:26 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829870
Page 151 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
3Mar-09-2021 10:28:20 (UTC-05:00) Eastern
Time (US & Canada)
3Mar-08-2021 12:24:26 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829871
Page 152 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
4Mar-09-2021 10:28:20 (UTC-05:00) Eastern
Time (US & Canada)
4Mar-08-2021 12:24:26 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0829872
Page 153 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
2Oct-07-2020 13:43:32 (UTC-05:00) Eastern
Time (US & Canada)Luis Monsalve There has been no further information about the
hospitalization and some of the fields are
unknown at this time
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0829873
Page 154 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
ItemDate User Comment
FormJan-19-2021 08:25:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829874
Page 155 of 278
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Jan-27-2021 12:31:39 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mohamed
Al-ibrahim Approved Jan-26-2021 16:30:05 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MohamedAl-ibrahim, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-18-2020 16:36:23 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mohamed
Al-ibrahim Approved Nov-10-2020 12:57:16 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MohamedAl-ibrahim, 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.
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829875
Page 156 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-13-2020 14:13:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-13-2020 14:13:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829876
Page 157 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-13-2020 14:13:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Sep/11/2020Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829877
Page 158 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-08-2020
02:24:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Event entered in Inform.
Issue resolved
Oct-07-2020
20:46:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per query
Oct-05-2020
09:33:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020381724
mild stroke
hospitalization(onset
date:23Sep2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Sep-13-2020
14:13:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12481120Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Nov-06-2020
06:43:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed DOB year updated to 1945
in Safety. issue resolved
Nov-05-2020
05:38:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candi
dateSAE RECON: Pending
SDB update
Nov-04-2020 ACV0PFEINFP6000 Query 1: Answered Updated SAE Formed
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829878
Page 159 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
13:07:18
(UTC-05:00) Eastern
Time (US & Canada)faxed to DSU: 04Nov2020.
Nov-03-2020
06:16:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opene
dSAE RECON 4: Per PSSR
Comment 'In checking with
the DSU- As per last
follow-up received on
05Oct2020, DOB was
updated to 1944. In case
this needs to be updated to
1945, kindly provide an
updated SAE form report.'
Oct-30-2020
07:31:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candi
dateFor PSSR review.
Oct-29-2020
14:07:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered As per PI, this has been
submitted and re-submitted
multiple times.
Oct-24-2020
10:15:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opene
dSAE RECON 3:A follow
up AEM form is required
to update the Date of birth
in Safety database.If the
correct date is 1945
per previous query
response. Please submit
follow up AEM form to
correct the date of birth in
safety database.
Oct-23-2020
09:58:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is correct
Oct-21-2020
06:13:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opene
dSAE RECON 2: Per latest
SAE listing the year of
birth is still 1944. Please
submit follow up AEM
form to correct the date of
birth in safety database.
Oct-21-2020
01:14:56ACV0PFEINFP6000 Query 1: Reissued:Candi
dateSAE RECON: To check
SAE listing if DOB will be
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829879
Page 160 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
(UTC-05:00) Eastern
Time (US & Canada)updated
Oct-20-2020
13:46:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per query
Oct-17-2020
08:49:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opene
dSAE RECON 1:Per query
response 'Original value is
correct' however, based on
latest SAE listing, the year
of birth reported to Safety
database is 1944. Please
confirm if follow up AEM
form was submitted to
update date of birth in
SDB.
Oct-16-2020
15:33:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is correct
Oct-08-2020
05:37:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020381724
,the date of birth was
reported as 1944 to
Safety but was recorded
1945 in AE CRF.
Please confirm if date of
birth was reported. If safety
update is required, please
submit a follow-up form
Sep-13-2020
14:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1945Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-13-2020 14:13:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (6)
(b) (6)
(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-2021-5683-0829880
Page 161 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
4. Ethnicity:
Date Location User Value Reason
Sep-13-2020 14:13:29
(UTC-05:00) Eastern
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-13-2020 14:13:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN AMER
ICANInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829881
Page 162 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-30-2020 06:25:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-29-2020 14:28:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Oct-05-2020 10:56:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Details on
visit ‘V2VX2L’ are
missing. Kindly
consider to update
or else clarify.
Thank you.
Sep-13-2020 14:13:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829882
Page 163 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-13-2020 14:14:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-13-2020 14:14:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-13-2020 14:14:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829883
Page 164 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1.a
Date Location User Value Reason
Sep-13-2020 14:14:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:Hypertension
Start Date: UNK/UNK/2
017
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-13-2020 14:14:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020 16:10:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Closed SAE update noted.
Oct-02-2020 17:17:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Opened Per SDB subject
was hospitalized
during 8 days, but
event and other
clinical information
has not been
detailed yet. Please
update AE log with
event and submit
FU SAE form with
relevant
information.
Sep-13-2020 14:14:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0829884
Page 165 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
1.a Start Date:
Date Location User Value Reason
Sep-13-2020 14:14:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-13-2020 14:14:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-13-2020 14:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
erm:Stroke
Start Date: UNK/UNK/2
014
Ongoing: YESInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829885
Page 166 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
1.b Line/MH Number:
Date Location User Value Reason
Sep-13-2020 14:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-13-2020 14:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
StrokeInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-13-2020 14:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-13-2020 14:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-13-2020 14:15:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History T
erm:Arthritis
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829886
Page 167 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
1.c Line/MH Number:
Date Location User Value Reason
Sep-13-2020 14:15:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-13-2020 14:15:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ArthritisInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-13-2020 14:15:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-13-2020 14:15:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-13-2020 14:16:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Penicillin/Sulfa
Hives
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829887
Page 168 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
1.d Line/MH Number:
Date Location User Value Reason
Sep-13-2020 14:16:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-13-2020 14:16:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Penicillin/Sulfa HivesInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-13-2020 14:16:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-13-2020 14:16:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829888
Page 169 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Date:
Date Location User Value Reason
Sep-13-2020 14:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-13-2020 14:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
119.3Initial Entry
3. Unit:
Date Location User Value Reason
Sep-13-2020 14:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-13-2020 14:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
180.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-13-2020 14:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-13-2020 14:17:03
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
36.8Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829889
Page 170 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-13-2020 14:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 36.9
Temperature Uni
t:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-13-2020 14:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-13-2020 14:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-13-2020 14:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-13-2020 14:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829890
Page 171 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-13-2020 14:17:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-13-2020 14:17:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-13-2020 14:17:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-13-2020 14:17:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-13-2020 14:17:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-13-2020 14:17:18 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829891
Page 172 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Sep-13-2020 14:17:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-13-2020 14:17:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-13-2020 14:17:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829892
Page 173 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-13-2020 14:17:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-13-2020 14:17:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
256789Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829893
Page 174 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-13-2020 14:19:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-13-2020 14:19:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-13-2020 14:19:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-13-2020 14:19:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-13-2020 14:19:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
Sep-13-2020 14:19:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8LC4Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829894
Page 175 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
5.a Sample ID
Date Location User Value Reason
Sep-13-2020 14:19:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8LC4Initial Entry
5.b
Date Location User Value Reason
Sep-13-2020 14:20:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMNXY1Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-13-2020 14:20:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMNXY1Initial Entry
5.c
Date Location User Value Reason
Sep-13-2020 14:20:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMNXY2Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-13-2020 14:20:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMNXY2Initial Entry
5.d
Date Location User Value Reason
Sep-13-2020 14:20:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMNXY3Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829895
Page 176 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
5.d Sample ID
Date Location User Value Reason
Sep-13-2020 14:20:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMNXY3Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829896
Page 177 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-13-2020 14:18:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-13-2020 14:18:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-13-2020 14:18:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-13-2020 14:18:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-13-2020 14:18:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
Sep-13-2020 14:18:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8LC0Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829897
Page 178 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
5.a Sample ID
Date Location User Value Reason
Sep-13-2020 14:18:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8LC0Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829898
Page 179 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-13-2020 14:17:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-13-2020 14:17:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-13-2020 14:17:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-13-2020 14:17:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020 15:41Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-13-2020 14:17:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-13-2020 14:17:58
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829899
Page 180 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-13-2020 14:17:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-13-2020 14:17:58
(UTC-05:00) Eastern
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-13-2020 14:17:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829900
Page 181 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-13-2020 14:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829901
Page 182 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-02-2020 03:37:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed TDV details
updated
Oct-30-2020 11:15:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Updated
Oct-30-2020 04:49:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened PDQ: DOV at this
visit is out of
window (17 day)
from DOV (11/Sep
/2020) at
V1D1VX1L. Please
either update DOV
or confirm whether
visit is out of
window due to
temporary delay of
vaccination/ else
provide details as
appropriate.
Oct-29-2020 14:16:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829902
Page 183 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Date:
Date Location User Value Reason
Oct-29-2020 14:18:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-29-2020 14:18:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Transcription Error
Oct-29-2020 14:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Vital Signs Date is
not same as
Vaccination Date in
the same visit.
Please review and
update as
appropriate or
clarify.
Oct-29-2020 14:17:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/28/2020Initial Entry
2.a
Date Location User Value Reason
Oct-29-2020 14:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 36.7
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYTranscription Error
Oct-29-2020 14:17:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 36.7
Temperature Unit
:FInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829903
Page 184 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Temperature Loc
ation::ORAL CAV
ITY
2.a Record Identifier:
Date Location User Value Reason
Oct-29-2020 14:17:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-29-2020 14:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-29-2020 14:17:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 36.7 F
is outside of Normal
Range 97 - 99.5 F.
Oct-29-2020 14:17:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-29-2020 14:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CTranscription Error
Oct-29-2020 14:17:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-29-2020 14:17:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829904
Page 185 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-29-2020 14:17:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-29-2020 14:17:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-29-2020 14:17:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-29-2020 14:17:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-29-2020 14:17:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-29-2020 14:17:39 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829905
Page 186 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Oct-29-2020 14:17:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-29-2020 14:17:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-29-2020 14:17:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829906
Page 187 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-29-2020 14:19:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020 14:19:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020 14:19:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-29-2020 14:19:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-29-2020 14:19:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-29-2020 14:19:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW1GBInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829907
Page 188 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
5.a Sample ID
Date Location User Value Reason
Oct-29-2020 14:19:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPW1GBInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829908
Page 189 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-30-2020 11:15:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of First Delay:
Oct/1/2020
Reason(s) for Temporary Delay
of Vaccination
FEVER OR ACUTE ILLNES
SNew Information
Oct-29-2020 14:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-29-2020 14:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-29-2020 14:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-29-2020 14:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020 13:13Initial Entry
5. Anatomical Location:
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829909
Page 190 of 278
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Date Location User Value Reason
Oct-29-2020 14:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-29-2020 14:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-29-2020 14:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-29-2020 14:17:59
(UTC-05:00) Eastern
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
Oct-29-2020 14:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829910
Page 191 of 278
***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, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-18-2020 16:36:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/18/2020Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829911
Page 192 of 278
***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, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-18-2020 16:36:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-18-2020 16:36:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-18-2020 16:36:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-18-2020 16:36:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-18-2020 16:36:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/18/2020Initial Entry
5.a
Date Location User Value Reason
Nov-18-2020 16:36:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRFZ45Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829912
Page 193 of 278
***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, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
5.a Sample ID
Date Location User Value Reason
Nov-18-2020 16:36:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRFZ45Initial Entry
5.b
Date Location User Value Reason
Nov-18-2020 16:37:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS7YY3Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-18-2020 16:37:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS7YY3Initial Entry
5.c
Date Location User Value Reason
Nov-18-2020 16:37:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS7YY4Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-18-2020 16:37:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS7YY4Initial Entry
5.d
Date Location User Value Reason
Nov-18-2020 16:37:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS7YY5Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829913
Page 194 of 278
***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, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
5.d Sample ID
Date Location User Value Reason
Nov-18-2020 16:37:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS7YY5Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829914
Page 195 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-05-2020 04:32:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Closed as per
comment on SWAB.
updated PD tracker
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-04-2020 07:38:37
(UTC-05:00) Eastern
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.
Nov-04-2020 07:38:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Nov-04-2020 07:38:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-04-2020 07:38:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829915
Page 196 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-06-2020 06:37:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as per site
response.
Nov-04-2020 07:39:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject tested
positive for Covid
during
hospitalization for
SAE; subject reports
they never has any
Covid symptoms.
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened All symptoms are
reported as Not
Present and there is
no Other Symptom
reported. Please
review and update
as appropriate.
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-06-2020 22:16:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-06-2020 11:30:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-06-2020 09:56:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered As per other CRF
Illness visit pages,
subject was
asymptomatic but
tested positive while
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829916
Page 197 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
in the hospital for an
unrelated SAE. No
answers for #2 or #3
based on this data.
Nov-06-2020 03:51:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for Data item#2 and
3 are missing.
Kindly review and
update.
3. Symptoms Ongoing?
Date Location User Value Reason
Nov-06-2020 11:30:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4.a
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829917
Page 198 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829918
Page 199 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
4.c Symptoms:
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORT
NESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAINInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829919
Page 200 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Symptom
Present:NO
4.e Symptoms:
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
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
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829920
Page 201 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
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
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829921
Page 202 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
4.i
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-04-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829922
Page 203 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
Date Location User Value Reason
Nov-04-2020 07:41:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829923
Page 204 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-04-2020 07:41:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/27/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-04-2020 07:41:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-04-2020 07:41:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-04-2020 07:41:43
(UTC-05:00) Eastern
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
Nov-04-2020 07:41:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Nov-04-2020 07:41:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829924
Page 205 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
7. Test Result:
Date Location User Value Reason
Nov-04-2020 07:41:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
POSITIVEInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Nov-04-2020 07:41:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Subject was tested while in hospit
al for SAE; subject denies ever ha
ving COVID symptomsInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Nov-04-2020 07:41:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NALT unknownInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829925
Page 206 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: 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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-04-2020 07:42:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-04-2020 07:42:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-04-2020 07:42:14
(UTC-05:00) Eastern
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
Nov-04-2020 07:42:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Subject was hospitalized for SAE;
COVID test performed there.Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829926
Page 207 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-04-2020 07:42:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-04-2020 07:42:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-04-2020 07:42:22
(UTC-05:00) Eastern
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
Nov-04-2020 07:42:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Subject was hospitalized for SAE;
COVID test performed there.Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829927
Page 208 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1.a
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
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
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practition
er:EMERGEN
CY ROOM
Occurrence of Vis
its or Contacts:NOInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829928
Page 209 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Conta
cts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829929
Page 210 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner
:URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829930
Page 211 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits or
Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Nov-04-2020 07:42:58
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829931
Page 212 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Time (US & Canada)
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0829932
Page 213 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Nov-04-2020 07:44:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNES
SInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Nov-09-2020 13:33:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-09-2020 12:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed
Information
Nov-09-2020 12:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOChanged
Information
Nov-07-2020 22:14:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Rupal N Shah Query 2: Opened CLIQUERY: Since
per SOD form,
subject is
Asymptomatic,
diagnosis should be
reported as "NO".
Nov-06-2020 14:17:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-05-2020 09:41:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Updated
Nov-05-2020 06:58:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Since per SOD
form, subject is
Asymptomatic,
please review if
response to "Was a
diagnosis obtained
for Potential
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0829933
Page 214 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
COVID-19 Illness?"
should be No and
toxicity Grade as
'0". Please update as
appropriate or else
clarify.
Nov-04-2020 07:44:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness Diagnosi
s:
COVID-19
Date of Diagnosis:
Sep/27/2020Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-09-2020 13:33:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-09-2020 12:03:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Updated
Nov-09-2020 02:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical Query:
COVID-19
diagnosis should not
be entered on this
CRF unless there
was a local positive
test and symptoms
recorded. As subject
is Asymptomatic,
please update.
Nov-06-2020 15:04:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Candidate Clinical Query:
COVID-19
diagnosis should not
be entered on this
CRF unless there
was a local positive
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829934
Page 215 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/02/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
test and symptoms
recorded. As subject
is Asymptomatic,
please update.
Nov-06-2020 15:03:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed error
Nov-06-2020 14:59:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical Query:
COVID-19
diagnosis should not
be entered on this
CRF unless there
was a local positive
test and symptoms
recorded. As no
local positive test
recorded in COVID
TEST CRF, please
update.
Nov-05-2020 09:41:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
0updated
Nov-04-2020 07:44:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829935
Page 216 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-10-2021 04:44:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted as per site
comments updated
on swab forms
Mar-10-2021 02:01:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed This will be checked
post BLA
Mar-09-2021 10:32:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Attempting to
schedule COV visit
with participant - no
date at this time
Mar-09-2021 10:29:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Mar-09-2021 06:21:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened PDQ: Convalescent
visit is missing and
35+ days (47) 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.
Mar-09-2021 03:36:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened PDQ: Date of Visit
is completed but
Date of Collection
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829936
Page 217 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
in both Nasal Swab
Self and Nasal Swab
are missing. Please
review and update
as appropriate.
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Mar-08-2021 12:17:44
(UTC-05:00) Eastern
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.
Mar-08-2021 12:17:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Mar-08-2021 12:17:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/21/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Mar-08-2021 12:17:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_BInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829937
Page 218 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Mar-09-2021 08:49:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-08-2021 12:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Mar-08-2021 12:23:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/8/2021Transcription Error
Mar-08-2021 12:22:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/21/2021Transcription Error
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of assessment
is not same as Date
Visit. Please check
and correct.
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/8/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/21/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolved
:Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0829938
Page 219 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Jan/21/2021
4.a
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom
Present:NOInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829939
Page 220 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
4.b Symptoms:
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORT
NESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829940
Page 221 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAIN
Symptom
Present:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829941
Page 222 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
4.f
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829942
Page 223 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
4.g Symptoms:
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: YESInitial Entry
4.h Symptoms:
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (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-2021-5683-0829943
Page 224 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
4.i Symptoms:
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Mar-08-2021 12:19:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0829944
Page 225 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Mar-08-2021 12:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Mar-08-2021 12:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Mar-08-2021 12:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Mar-08-2021 12:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Mar-08-2021 12:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Mar-08-2021 12:19:31 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196f28347\Final\Final On: 04-May-2021 13:17 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0829945
Page 226 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/21/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481120 Subject Initials: ---
Generated By: Generated Time (GMT): 04-May-2021 12:42
(UTC-05:00) Eastern
Time (US & Canada)Not Done
7. Test Result:
Date Location User Value Reason
Mar-08-2021 12:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Mar-08-2021 12:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Mar-08-2021 12:19:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial
…[truncated]