125742 S1 M5 CRF c4591001 1178 11781122

Document text

Page 1 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817158
Page 2 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/8/2020
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817159
Page 3 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11781122]
2.Birth Date: /1947
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817160
Page 4 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817161
Page 5 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817162
Page 6 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/8/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817163
Page 7 of 255
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cardiomyopathy]
Start Date: UNK/UNK/2008
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left ventricular hypertrophy]
Start Date: UNK/UNK/2008
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2000
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gout]
Start Date: Feb/UNK/2018
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[atrial fibrillation]
Start Date: Jan/UNK/2020
Ongoing: YES
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817164
Page 8 of 255
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[elevate prostate-specific antigen]
Start Date: UNK/UNK/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hiatal hernia]
Start Date: UNK/UNK/1947
Ongoing: YES
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817165
Page 9 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
2.Weight: [222.0]
3.Unit: LB
4.Height: [70.5]
5.Unit: in
6.Body Mass Index: [31.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817166
Page 10 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/8/2020
2.Randomization Number: [254895]
3.Randomization Group: [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817167
Page 11 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY8H4]
5.bSample ID [BNWP4R]
5.cSample ID [BNWP4S]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817168
Page 12 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY8H7]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817169
Page 13 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/8/2020 16:26
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
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817170
Page 14 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817171
Page 15 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817172
Page 16 of 255
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Sep/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817173
Page 17 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/28/2020
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 [BPW3KK]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817174
Page 18 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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/28/2020 14:03
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
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817175
Page 19 of 255
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817176
Page 20 of 255
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/26/2020
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 [BPW406]
5.bSample ID [BRVDYV]
5.cSample ID [BRVDYW]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817177
Page 21 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817178
Page 22 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/8/2021
2.Date of First Symptom Started: Feb/6/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/26/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817179
Page 23 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817180
Page 24 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of C
ollectionSpecimen Typ
eSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/31/202
1 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
 2.Feb/10/20
21 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
 3.Feb/10/20
21 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817181
Page 25 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/31/2021 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [NALT Unknown] Comments
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817182
Page 26 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Feb/10/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [Ortho's VITROS SARS-CoV-2 Antigen Test]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817183
Page 27 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Feb/10/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [Accula SARS CoV 2 Test]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817184
Page 28 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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:[In-Clinic Visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817185
Page 29 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
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 [BR7SHR]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817186
Page 30 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817187
Page 31 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817188
Page 32 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817189
Page 33 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19 Illness]
Date of Diagnosis:
Feb/10/2021
3.Toxicity Grade: 1
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817190
Page 34 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817191
Page 35 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817192
Page 36 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817193
Page 37 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817194
Page 38 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#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
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817195
Page 39 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817196
Page 40 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817197
Page 41 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817198
Page 42 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817199
Page 43 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817200
Page 44 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817201
Page 45 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817202
Page 46 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817203
Page 47 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817204
Page 48 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817205
Page 49 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817206
Page 50 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/01/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit Not Applicable Comments
COVID-19 Illness Visit
3.COVID-19 Illness Visit: Not Applicable Comments
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817207
Page 51 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/01/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Applicable
[ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817208
Page 52 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817209
Page 53 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unplanned Assessments
1.Assessments
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817210
Page 54 of 255
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/26/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817211
Page 55 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817212
Page 56 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817213
Page 57 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817214
Page 58 of 255
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  Basal Cell Carcinoma (fa
ce) Oct/15/2020 09
:00 NO
End Date Time:
Oct/29/2020 UNK:
UNK
 Repeating
Pages
 2. DELETED ADVERSE
EVENT 2  basal cell carcinoma  Nov/15/2020 U
NK:UNK NO
End Date Time:
Dec/15/2020 UNK:
UNK
 Repeating
Pages
 3. ADVERSE
EVENT 3  tenderness at injection sit
e Jan/22/2021 U
NK:UNK NO
End Date Time:
Jan/29/2021 11:00
 Repeating
Pages
 4. ADVERSE
EVENT 4  worsening of paroxysmal
atrial fibrillation Jan/14/2021 U
NK:UNK NO
End Date Time:
Feb/4/2021 UNK:U
NK
 Repeating
Pages
 5. ADVERSE
EVENT 5  intestinal obstruction  Feb/9/2021 UN
K:UNK NO
End Date Time:
Feb/19/2021 UNK:
UNK
 Repeating
Pages
 6. ADVERSE
EVENT 6  GERD  Feb/4/2021 UN
K:UNK YES  Repeating
Pages
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817215
Page 59 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Basal Cell Carcinoma (face)]
4.Start Date Time: Oct/15/2020 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/29/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Mitosis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817216
Page 60 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817217
Page 61 of 255
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** 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)[basal cell carcinoma ]
4.Start Date Time: Nov/15/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/15/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817218
Page 62 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817219
Page 63 of 255
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[tenderness at injection site]
4.Start Date Time: Jan/22/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/29/2021 11:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817220
Page 64 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817221
Page 65 of 255
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[worsening of paroxysmal atrial fibrillation]
4.Start Date Time: Jan/14/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/4/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817222
Page 66 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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:
[hx of atrial fibrillation]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021148943]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817223
Page 67 of 255
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[intestinal obstruction]
4.Start Date Time: Feb/9/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/19/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817224
Page 68 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
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[2021195271]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817225
Page 69 of 255
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[GERD]
4.Start Date Time: Feb/4/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
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:
[acid in wrong location]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817226
Page 70 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817227
Page 71 of 255
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
 1.          Repeating
Pages
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817228
Page 72 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817229
Page 73 of 255
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart Dat
eForm Instanc
e
 1.1  VACCINATIONS  NO  influenza vacci
ne Oct/27/2
020 Repeating
Pages
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817230
Page 74 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[influenza vaccine]
5.Date: Oct/27/2020
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817231
Page 75 of 255
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817232
Page 76 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817233
Page 77 of 255
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817234
Page 78 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817235
Page 79 of 255
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817236
Page 80 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817237
Page 81 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817238
Page 82 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817239
Page 83 of 255
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817240
Page 84 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817241
Page 85 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817242
Page 86 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817243
Page 87 of 255
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817244
Page 88 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/15/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817245
Page 89 of 255
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817246
Page 90 of 255
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817247
Page 91 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817248
Page 92 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/19/2021
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817249
Page 93 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817250
Page 94 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/19/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817251
Page 95 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/19/2021
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 [BR7H0J]
5.bSample ID [BSGFGP]
5.cSample ID [BSGFGR]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817252
Page 96 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/19/2021
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 [BR7H0H]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817253
Page 97 of 255
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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/19/2021 14:40
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
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817254
Page 98 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817255
Page 99 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/1/2021
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 [BR7SMY]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817256
Page 100 of 255
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Feb/8/2021
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESS
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/1/2021 14:08
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
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817257
Page 101 of 255
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817258
Page 102 of 255
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817259
Page 103 of 255
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817260
Page 104 of 255
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817261
Page 105 of 255
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817262
Page 106 of 255
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817263
Page 107 of 255
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817264
Page 108 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/26/2020
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817265
Page 109 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817266
Page 110 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817267
Page 111 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-08-2020 17:39:21 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817268
Page 112 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormMar-02-2021 15:01:06 (UTC-06:00) Central
Time (US & Canada)
FormFeb-10-2021 14:26:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817269
Page 113 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Mar-02-2021 15:01:06 (UTC-06:00) Central Time
(US & Canada)
1Feb-10-2021 14:26:43 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817270
Page 114 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Mar-02-2021 15:01:06 (UTC-06:00) Central Time
(US & Canada)
2Feb-10-2021 14:26:43 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817271
Page 115 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Mar-02-2021 15:01:06 (UTC-06:00) Central Time
(US & Canada)
3Feb-10-2021 14:26:43 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817272
Page 116 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Mar-02-2021 15:01:06 (UTC-06:00) Central Time
(US & Canada)
4Feb-10-2021 14:26:43 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817273
Page 117 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Mar-02-2021 15:01:06 (UTC-06:00) Central Time
(US & Canada)
5Feb-10-2021 14:26:43 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817274
Page 118 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Mar-02-2021 15:01:06 (UTC-06:00) Central Time
(US & Canada)
6Feb-10-2021 14:26:43 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817275
Page 119 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Mar-02-2021 15:01:06 (UTC-06:00) Central Time
(US & Canada)
7Feb-10-2021 14:26:43 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817276
Page 120 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Mar-02-2021 15:01:06 (UTC-06:00) Central Time
(US & Canada)
8Feb-10-2021 14:26:43 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817277
Page 121 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
9Mar-02-2021 15:01:06 (UTC-06:00) Central Time
(US & Canada)
9Feb-10-2021 14:26:43 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817278
Page 122 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 Form: DATE OF VISIT - ILLNESS CONVALESCENT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Mar-02-2021 13:27:52 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817279
Page 123 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 Form: DATE OF VISIT - ILLNESS CONVALESCENT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Mar-02-2021 12:24:36 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817280
Page 124 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/01/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormMar-09-2021 08:32:26 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817281
Page 125 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Mar-09-2021 08:32:26 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817282
Page 126 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Mar-09-2021 08:32:26 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817283
Page 127 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Mar-09-2021 08:32:26 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817284
Page 128 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Mar-09-2021 08:32:26 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817285
Page 129 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormJan-19-2021 15:43:56 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817286
Page 130 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-02-2021 12:41:55 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephan Sharp  Approved Jan-20-2021 11:19:52 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephanSharp, 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-19-2020 16:08:25 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephan Sharp  Approved Nov-02-2020 09:55:04 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephanSharp, 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.
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817287
Page 131 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-08-2020 17:36:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-08-2020 17:36:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817288
Page 132 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-08-2020 17:36:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/8/2020Initial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817289
Page 133 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-08-2020 17:36:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11781122Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-08-2020 17:36:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1947Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-08-2020 17:37:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-08-2020 17:37:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-08-2020 17:37:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817290
Page 134 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020 17:39:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817291
Page 135 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-08-2020 17:39:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-08-2020 17:39:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-08-2020 17:39:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817292
Page 136 of 255
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.a
Date Location User Value Reason
Sep-08-2020 17:40:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:cardiomyopat
hy
Start Date: UNK/UNK/2
008
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-08-2020 17:40:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020 17:40:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cardiomyopathyInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-08-2020 17:40:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-08-2020 17:40:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817293
Page 137 of 255
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-08-2020 17:40:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:left ventricular hy
pertrophy
Start Date: UNK/UNK/2008
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-08-2020 17:40:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020 17:40:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
left ventricular hypertrophyInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-08-2020 17:40:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-08-2020 17:40:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-08-2020 17:41:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3Initial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817294
Page 138 of 255
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Medical History Te
rm:hypertension
Start Date: UNK/UNK/2
000
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-08-2020 17:41:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020 17:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-08-2020 17:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-08-2020 17:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-08-2020 17:41:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:gout
Start Date: Feb/UNK/20
18Initial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817295
Page 139 of 255
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-08-2020 17:41:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020 17:41:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
goutInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-08-2020 17:41:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-08-2020 17:41:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-08-2020 17:42:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:atrial fibrillati
on
Start Date: Jan/UNK/202
0
Ongoing: YESInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817296
Page 140 of 255
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.e Line/MH Number:
Date Location User Value Reason
Sep-08-2020 17:42:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020 17:42:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
atrial fibrillationInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-08-2020 17:42:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-08-2020 17:42:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-08-2020 17:43:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Histo
ry Term:elevate prostate-spe
cific antigen
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817297
Page 141 of 255
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.f Line/MH Number:
Date Location User Value Reason
Sep-08-2020 17:43:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020 17:43:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
elevate prostate-specific antigenInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-08-2020 17:43:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-08-2020 17:43:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Mar-02-2021 13:30:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Te
rm:hiatal hernia
Start Date: UNK/UNK/1
947
Ongoing: YESInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817298
Page 142 of 255
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.g Line/MH Number:
Date Location User Value Reason
Mar-02-2021 13:30:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-02-2021 13:30:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hiatal herniaInitial Entry
1.g Start Date:
Date Location User Value Reason
Mar-02-2021 13:30:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1947Initial Entry
1.g Ongoing:
Date Location User Value Reason
Mar-02-2021 13:30:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817299
Page 143 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020 17:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-08-2020 17:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
222.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-08-2020 17:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-08-2020 17:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
70.5Initial Entry
5. Unit:
Date Location User Value Reason
Sep-08-2020 17:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-08-2020 17:44:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31.4Initial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817300
Page 144 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7.a
Date Location User Value Reason
Sep-08-2020 17:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.9
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-08-2020 17:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-08-2020 17:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.9Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-08-2020 17:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-08-2020 17:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817301
Page 145 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-08-2020 17:44:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-08-2020 17:44:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
254895Initial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817302
Page 146 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 18:09:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 18:09:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020 18:09:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-08-2020 18:09:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-08-2020 18:09:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020 18:09:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY8H4Initial Entry
5.a Sample ID
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817303
Page 147 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-08-2020 18:09:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY8H4Initial Entry
5.b
Date Location User Value Reason
Sep-08-2020 18:09:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWP4RInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-08-2020 18:09:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNWP4RInitial Entry
5.c
Date Location User Value Reason
Sep-08-2020 18:09:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWP4SInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-08-2020 18:09:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNWP4SInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817304
Page 148 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 18:08:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 18:08:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020 18:09:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-08-2020 18:08:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-08-2020 18:08:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020 18:09:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY8H7Initial Entry
5.a Sample ID
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817305
Page 149 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-08-2020 18:09:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY8H7Initial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817306
Page 150 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-08-2020 17:45:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020 17:45:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020 17:45:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-08-2020 17:45:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020 16:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020 17:45:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-08-2020 17:45:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817307
Page 151 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7. Route:
Date Location User Value Reason
Sep-08-2020 17:45:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-08-2020 17:45:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-08-2020 17:45:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817308
Page 152 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-08-2020 17:45:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817309
Page 153 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-28-2020 16:23:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817310
Page 154 of 255
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Sep-28-2020 16:23:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
2.a
Date Location User Value Reason
Sep-28-2020 16:23:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.6
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-28-2020 16:23:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-28-2020 16:23:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-28-2020 16:23:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817311
Page 155 of 255
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-28-2020 16:23:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817312
Page 156 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 13:40:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 13:40:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020 13:40:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-28-2020 13:40:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-28-2020 13:40:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/28/2020Initial Entry
5.a
Date Location User Value Reason
Sep-30-2020 07:41:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPW3KKTranscription Error
Sep-28-2020 13:40:38 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0817313
Page 157 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-06:00) Central
Time (US & Canada)Sample ID: BPW3KL
5.a Sample ID
Date Location User Value Reason
Sep-30-2020 07:41:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPW3KKTranscription Error
Sep-28-2020 13:40:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPW3KLInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817314
Page 158 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-28-2020 16:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020 16:24:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020 16:24:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-28-2020 16:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020 14:03Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-28-2020 16:24:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-28-2020 16:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817315
Page 159 of 255
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7. Route:
Date Location User Value Reason
Sep-28-2020 16:24:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-28-2020 16:24:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-28-2020 16:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817316
Page 160 of 255
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-26-2020 13:19:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817317
Page 161 of 255
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020 13:41:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020 13:41:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-26-2020 13:41:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-26-2020 13:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-26-2020 13:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/26/2020Initial Entry
5.a
Date Location User Value Reason
Oct-26-2020 13:41:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPW406Initial Entry
5.a Sample ID
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817318
Page 162 of 255
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-26-2020 13:41:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPW406Initial Entry
5.b
Date Location User Value Reason
Oct-26-2020 13:41:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRVDYVInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-26-2020 13:41:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRVDYVInitial Entry
5.c
Date Location User Value Reason
Oct-26-2020 13:41:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRVDYWInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-26-2020 13:41:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRVDYWInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817319
Page 163 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-08-2021 10:16:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-08-2021 10:15:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Feb-08-2021 10:15:42
(UTC-06:00) Central
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.
Feb-08-2021 10:15:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/8/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-08-2021 10:15:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817320
Page 164 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/8/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/6/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-02-2021 14:50:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolved:
Feb/26/2021New Information
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817321
Page 165 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
4.a Was symptom present?
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF BR
EATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817322
Page 166 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
4.c Symptoms:
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAINInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817323
Page 167 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Symptom
Present:NO
4.e Symptoms:
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCLE
PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
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
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817324
Page 168 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREASE
D SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE TH
ROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817325
Page 169 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-08-2021 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817326
Page 170 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Feb-08-2021 15:41:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817327
Page 171 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Mar-02-2021 15:05:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817328
Page 172 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Mar-03-2021 11:21:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817329
Page 173 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Mar-04-2021 08:20:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Mar-03-2021 11:02:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Mar-03-2021 11:02:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/31/2021Transcription Error
Mar-03-2021 10:29:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Per source, date of
collection was
31-Jan-21. Please
review and update as
needed.
Mar-02-2021 15:04:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/2/2021Initial Entry
Mar-02-2021 15:01:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-11-2021 08:22:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-10-2021 14:26:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-10-2021 14:24:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Feb-10-2021 14:24:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Changed
Information
Feb-10-2021 12:29:41
(UTC-06:00) CentralACV0PFEINFP6000  Query 1: Opened Date of local
COVID test is prior
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817330
Page 174 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada) to date of symptom
onset. Please
confirm if local
COVID testing was
triggered by
potential COVID
symptoms?
Feb-08-2021 15:41:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/31/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Mar-02-2021 15:04:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
Mar-02-2021 15:01:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-10-2021 14:26:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-10-2021 14:26:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-08-2021 15:41:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Mar-02-2021 15:04:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
Mar-02-2021 15:01:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-10-2021 14:26:43 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0817331
Page 175 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-06:00) Central
Time (US & Canada)Not Applicable
Feb-10-2021 14:26:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-08-2021 15:41:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Mar-02-2021 15:04:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
Mar-02-2021 15:01:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
Feb-10-2021 14:26:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Feb-10-2021 14:24:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Changed Information
Feb-08-2021 15:41:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Mar-02-2021 15:04:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
Mar-02-2021 15:01:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
Feb-10-2021 14:26:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817332
Page 176 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Feb-10-2021 14:24:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Changed Information
Feb-08-2021 15:41:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Mar-03-2021 09:31:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-03-2021 09:31:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Trade Name is Other,
however Trade
Name Other, Specify
is not completed.
Please update.
Mar-02-2021 15:04:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
Mar-02-2021 15:01:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-10-2021 14:26:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-10-2021 14:26:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-08-2021 15:41:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Mar-02-2021 15:04:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817333
Page 177 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Mar-02-2021 15:01:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-10-2021 14:26:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-10-2021 14:26:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-08-2021 15:41:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Mar-02-2021 15:01:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-10-2021 14:26:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Mar-03-2021 13:15:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed data updated
Mar-03-2021 09:31:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NALT UnknownInitial Entry
Mar-03-2021 09:31:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Mar-03-2021 09:31:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817334
Page 178 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
9. Trade Name Other, Specify:
Date Location User Value Reason
Mar-03-2021 04:09:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened DM: As per CRF
CR Section 8.31.7,
If the Trade Name is
not known, please
enter “NALT
Unknown” in the
specified field,
Thank you.
Mar-02-2021 15:04:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SARS-CoV-2Initial Entry
Mar-02-2021 15:01:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-10-2021 14:26:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-10-2021 14:26:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-09-2021 15:10:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-09-2021 14:33:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-09-2021 14:33:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NALT UnknownTranscription Error
Feb-09-2021 12:19:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clin: Per CRF CRs
8.31.7, please
provide
manufacturer and
test kit name. If not
available, please
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817335
Page 179 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
enter if test
conducted at 'CLIA-
certified lab' or 'ISO
15189 accredited
lab.' If both trade
name and lab are not
known, enter 'NALT
Unknown.'
Feb-08-2021 15:41:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NALTInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817336
Page 180 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Mar-04-2021 14:45:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-04-2021 13:52:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Mar-04-2021 11:41:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clin: 2 local swabs
were recorded as
collected on
10Feb2021 with 1
positive result and 1
negative result,
please confirm.
Mar-02-2021 15:07:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021New Information
Mar-02-2021 15:05:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Mar-02-2021 15:05:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Mar-02-2021 15:05:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817337
Page 181 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Mar-02-2021 15:05:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Mar-02-2021 15:05:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Mar-02-2021 15:05:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Mar-02-2021 15:05:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
POSITIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Mar-08-2021
03:50:44
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: C
losedResponse
satisfies query
Mar-05-2021
08:02:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: A
nsweredNew
Information
Mar-05-2021
08:02:55
(UTC-06:00)ACV0PFEINFP6000  Data Entr
y:
Ortho's VINew
Information
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817338
Page 182 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Central Time
(US & Canada)TROS SA
RS-CoV-2
Antigen Te
st
Mar-05-2021
01:01:10
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 3: O
penedTrade name
Manufacturer
name provided
as Vitros Sars
COV 2 total
antibody assay
does not
uniquely match
with the FDA
List. Kindly
update data as
requested else
please confirm
and add text
"CLIA certified
lab", Thank you.
Mar-04-2021
08:21:00
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: C
losedResponse
satisfies query
Mar-03-2021
11:04:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: A
nsweredTranscription
Error
Mar-03-2021
11:04:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
Vitros Sars
-COV-2 tot
al antibody
assayTranscription
Error
Mar-03-2021
10:45:36
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: O
penedPer source, this
test was a Vitros
Sars-COV-2
total antibody
assay. Please
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0817339
Page 183 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
review and
update trade
name other field
as needed.
Mar-03-2021
10:45:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: C
losedUpdating text of
query
Mar-03-2021
10:41:29
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: O
penedPer source, this
test was a Vitro
Sars-COV-2
total antibody
assay. Please
review and
update trade
name other field
as needed.
Mar-03-2021
09:32:43
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
NALT Unk
nownTranscription
Error
Mar-02-2021
15:05:39
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
SARS-CoV
-2Initial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817340
Page 184 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Mar-03-2021 11:21:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Mar-03-2021 11:21:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALTranscription Error
Mar-03-2021 11:21:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RESPIRATORY SECRETIONSInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Mar-03-2021 11:21:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Mar-03-2021 11:21:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Mar-03-2021 11:21:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817341
Page 185 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Mar-03-2021 11:21:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Mar-03-2021 11:21:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Mar-05-2021
05:07:06
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: C
losedResponse
satisfies query
Mar-04-2021
07:43:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: A
nsweredTranscription
Error
Mar-04-2021
07:43:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
Accula SA
RS CoV 2
TestTranscription
Error
Mar-04-2021
06:00:20
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: O
penedAs per FDA List
of Trade names
and CRF CR,
data should be
updated as
Accula SARS
Cov 2 Test
.(Mesa Biotech
Inc.) Kindly
confirm and
update data as
requested, else
clarify, Thank
you. 
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0817342
Page 186 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Mar-03-2021
11:25:54
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
Accula SA
RS-CoV-2
molecular
PCRTranscription
Error
Mar-03-2021
11:21:21
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
Accula SA
RS-CoV-2
molecular t
estInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0817343
Page 187 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-08-2021 15:42:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-08-2021 15:42:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-08-2021 15:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-08-2021 15:42:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
In-Clinic VisitInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817344
Page 188 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-08-2021 10:16:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-08-2021 10:16:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-08-2021 10:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-08-2021 10:16:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-08-2021 10:16:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/8/2021Initial Entry
5.a
Date Location User Value Reason
Feb-08-2021 10:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR7SHRInitial Entry
5.a Sample ID
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817345
Page 189 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Feb-08-2021 10:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR7SHRInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817346
Page 190 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.a
Date Location User Value Reason
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:EMERGENC
Y ROOM
Occurrence of Visi
ts or Contacts:NOInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817347
Page 191 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of V
isits or Contacts
:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817348
Page 192 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Feb-08-2021 15:42:43
(UTC-06:00) Central
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
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of V
isits or Contacts
:NOInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817349
Page 193 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Feb-10-2021 14:27:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or
Contacts:NOInitial Entry
Feb-10-2021 14:27:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or
Contacts:Transcription Error
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:OTHER
Occurrence of
Visits or Conta
cts:YES
Number of Visi
ts or Contacts:
1Initial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817350
Page 194 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-10-2021 14:27:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
Feb-10-2021 14:27:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
2. Other Type of Practitioner Specify:
Date Location User Value Reason
Feb-10-2021 14:27:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-09-2021 15:10:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-09-2021 14:32:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-09-2021 14:32:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Vanderbilt Hospital COVID-19 Te
stingTranscription Error
Feb-09-2021 12:20:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clin: Please specify
practitioner. If this
was COVID-19
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817351
Page 195 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
testing, please
specify.
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Vanderbilt HospitalInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Feb-08-2021 15:42:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817352
Page 196 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Feb-08-2021 15:43:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Mar-03-2021 09:33:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Diagnosis:
COVID-19 Illness
Date of Diagnosis:
Feb/10/2021New Information
Feb-08-2021 15:43:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Feb-08-2021 15:43:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817353
Page 197 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/01/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021 13:27:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-02-2021 08:45:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: As visit is
initiated in error,
please consider
adding form level
comment "Not
applicable" in this
form. Thank you.
Mar-01-2021 15:44:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please either untick
the erroneous visit
button if visit
occurred, or mark
any forms
containing data
within this visit as
Not Done/Not
Applicable at the
form level.
Mar-01-2021 15:43:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/1/2021Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-02-2021 13:27:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Mar-02-2021 13:27:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817354
Page 198 of 255
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/01/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Mar-01-2021 15:44:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Mar-02-2021 12:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Mar-01-2021 15:44:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-01-2021 15:43:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817355
Page 199 of 255
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/01/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-09-2021 08:32:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-09-2021 08:32:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-09-2021 08:32:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Mar-09-2021 08:32:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817356
Page 200 of 255
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-26-2020 13:20:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-26-2020 13:20:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-26-2020 13:20:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817357
Page 201 of 255
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Oct-26-2020 13:22:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817358
Page 202 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Jan-19-2021 15:49:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Jan-19-2021 15:46:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817359
Page 203 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Feb-02-2021 14:21:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817360
Page 204 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Feb-08-2021 15:47:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817361
Page 205 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Feb-22-2021 18:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817362
Page 206 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Mar-02-2021 13:33:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817363
Page 207 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Oct-26-2020 13:22:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-26-2020 13:22:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-26-2020 13:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Basal Cell Carcinoma (face)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-26-2020 13:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020 09:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-19-2020 16:08:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/29/2020 UNK:UNKNew Information
Oct-26-2020 13:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817364
Page 208 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-26-2020 13:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-26-2020 13:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-26-2020 13:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-26-2020 13:23:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
MitosisNew Information
Oct-26-2020 13:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817365
Page 209 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-26-2020 13:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-26-2020 13:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-26-2020 13:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-19-2020 16:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-19-2020 16:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-19-2020 16:08:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Basal Cell
Carcinoma (face):
Response to "What
was the outcome of
this adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Oct-26-2020 13:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (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-2021-5683-0817366
Page 210 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-26-2020 13:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817367
Page 211 of 255
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Jan-19-2021 15:46:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-19-2021 15:46:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-19-2021 15:46:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
basal cell carcinomaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-19-2021 15:46:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/15/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-19-2021 15:46:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/15/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fa9\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817368
Page 212 of 255
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781122 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-19-2021 15:46:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-19-2021 15:46:34
(UTC-06:00) Central
T
…[truncated]