125742 S1 M5 CRF c4591001 1156 11561131

Document text

Page 1 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841355
Page 2 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/11/2020
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841356
Page 3 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11561131]
2.Birth Date: /1974
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0841357
Page 4 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/11/2020
2.Erroneous Visit
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841358
Page 5 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841359
Page 6 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841360
Page 7 of 210
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[complex injury of left hand]
Start Date: Sep/17/2016
Ongoing: NO
End Date:
Sep/17/2016
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[reconstruction of forearm wound with fasciocutaneous flap]
Start Date: Sep/17/2016
Ongoing: NO
End Date:
Sep/17/2016
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841361
Page 8 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/11/2020
2.Weight: [75.6]
3.Unit: kg
4.Height: [176.78]
5.Unit: cm
6.Body Mass Index: [24.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841362
Page 9 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/11/2020
2.Randomization Number: [86980]
3.Randomization Group: [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841363
Page 10 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/11/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP18JZ]
5.bSample ID [BPHS59]
5.cSample ID [BPHS5B]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841364
Page 11 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/11/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP18K7]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841365
Page 12 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/11/2020 11:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841366
Page 13 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841367
Page 14 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841368
Page 15 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/30/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841369
Page 16 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
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 [BP18V2]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841370
Page 17 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/30/2020 16:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841371
Page 18 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841372
Page 19 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/30/2020
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 [BR69S2]
5.bSample ID [BRZPW3]
5.cSample ID [BRZPW4]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841373
Page 20 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/29/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841374
Page 21 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/29/2020
2.Date of First Symptom
Started:Dec/28/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/1/2021
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
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841375
Page 22 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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? YES
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841376
Page 23 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice T
ypeForm Instan
ce
 1.Not Applic
able Not Appli
cable Not Applicable  Not Applicable  Not Appli
cable Repeating
Pages
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841377
Page 24 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection
Location:Not Applicable Comments
4.Assay Code and
Description:Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings
/Details:Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841378
Page 25 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:[SWAB PFE]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841379
Page 26 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/29/2020
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 [BR3NGV]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841380
Page 27 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841381
Page 28 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841382
Page 29 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841383
Page 30 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841384
Page 31 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 1
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841385
Page 32 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841386
Page 33 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical
Event:Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841387
Page 34 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841388
Page 35 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841389
Page 36 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841390
Page 37 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841391
Page 38 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841392
Page 39 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:[ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841393
Page 40 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841394
Page 41 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841395
Page 42 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841396
Page 43 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841397
Page 44 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841398
Page 45 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841399
Page 46 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.        Repeating
Pages
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841400
Page 47 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841401
Page 48 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/26/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841402
Page 49 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/26/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
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 [BR38V3]
5.bSample ID [BS60GD]
5.cSample ID [BS60GC]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841403
Page 50 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841404
Page 51 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841405
Page 52 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841406
Page 53 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841407
Page 54 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841408
Page 55 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841409
Page 56 of 210
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still
ongoing?
6.Toxicity Grade:
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).
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841410
Page 57 of 210
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with
Study Treatment:
11.Was a Concomitant
Medication given?
12.Was a Non-Drug Treatment
given?
13.What was the outcome of
this adverse event?:
14.Did the adverse event cause
the subject to be
discontinued from the
study?
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841411
Page 58 of 210
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841412
Page 59 of 210
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841413
Page 60 of 210
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841414
Page 61 of 210
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841415
Page 62 of 210
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841416
Page 63 of 210
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841417
Page 64 of 210
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841418
Page 65 of 210
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841419
Page 66 of 210
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841420
Page 67 of 210
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841421
Page 68 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841422
Page 69 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841423
Page 70 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841424
Page 71 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841425
Page 72 of 210
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841426
Page 73 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841427
Page 74 of 210
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841428
Page 75 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/22/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841429
Page 76 of 210
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841430
Page 77 of 210
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841431
Page 78 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841432
Page 79 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/25/2021
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841433
Page 80 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841434
Page 81 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841435
Page 82 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
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 [BRLYB2]
5.bSample ID [BS2F7B]
5.cSample ID [BS2F79]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841436
Page 83 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
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 [BRLYBL]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841437
Page 84 of 210
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/25/2021 15:58
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841438
Page 85 of 210
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841439
Page 86 of 210
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841440
Page 87 of 210
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841441
Page 88 of 210
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841442
Page 89 of 210
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841443
Page 90 of 210
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841444
Page 91 of 210
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841445
Page 92 of 210
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841446
Page 93 of 210
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841447
Page 94 of 210
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841448
Page 95 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/30/2020
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841449
Page 96 of 210
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841450
Page 97 of 210
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Hector
Rodriguez Approved Mar-04-2021 12:13:17 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841451
Page 98 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-11-2020 14:27:21 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841452
Page 99 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-30-2020 09:42:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841453
Page 100 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-30-2020 09:42:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841454
Page 101 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Dec-30-2020 09:42:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841455
Page 102 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Dec-30-2020 09:42:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841456
Page 103 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Dec-30-2020 09:42:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841457
Page 104 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Dec-30-2020 09:42:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841458
Page 105 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Dec-30-2020 09:42:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841459
Page 106 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
7Dec-30-2020 09:42:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841460
Page 107 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
8Dec-30-2020 09:42:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841461
Page 108 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
9Dec-30-2020 09:42:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841462
Page 109 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-08-2021 15:13:12 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841463
Page 110 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Jan-08-2021 15:13:12 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841464
Page 111 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Jan-08-2021 15:13:12 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841465
Page 112 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Jan-08-2021 15:13:12 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841466
Page 113 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Jan-08-2021 15:13:12 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841467
Page 114 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormFeb-25-2021 17:41:28 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841468
Page 115 of 210
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Hector
Rodriguez Approved Mar-04-2021 12:13:17 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
Hector
Aguilar N/A Jan-26-2021 16:28:03 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Jan-23-2021 14:20:32 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841469
Page 116 of 210
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
Hector
Aguilar N/A Dec-30-2020 09:41:41 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Nov-04-2020 14:35:54 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841470
Page 117 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-11-2020
14:26:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-11-2020
14:26:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841471
Page 118 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-11-2020
14:26:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/11/2020Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841472
Page 119 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-11-2020
14:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11561131Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-11-2020
14:26:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1974Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-11-2020
14:26:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841473
Page 120 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-11-2020
14:26:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
HISPANIC OR LATI
NO(A) OR OF SPA
NISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-11-2020
14:26:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BLACK OR AFRIC
AN AMERICANInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841474
Page 121 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-11-2020
14:27:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/11/2020Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841475
Page 122 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-11-2020
14:27:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-11-2020
14:27:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-11-2020
14:27:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
COMPLETEDInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841476
Page 123 of 210
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Sep-11-2020
14:29:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical
History
Term:complex inj
ury of left h
and
Start Dat
e:Sep/17/201
6
Ongoing: NO
End Date:
Sep/17/2
016Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-11-2020
14:29:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841477
Page 124 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-11-2020
14:29:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
complex injury of lef
t handInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-11-2020
14:29:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/17/2016Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-11-2020
14:29:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Sep/17/2016Initial Entry
1.b
Date Location User Value Reason
Sep-11-2020
14:31:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/
MH N
umbe
r:2Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841478
Page 125 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Medic
al His
tory T
erm:reconstruction
of forearm wou
nd with fascioc
utaneous flap
Start
Date:Sep/17/2016
Ongoi
ng:NO
End Date:
Sep/17/201
6
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841479
Page 126 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b Line/MH Number:
Date Location User Value Reason
Sep-11-2020
14:31:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020
14:31:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
reconstruction of fore
arm wound with fasc
iocutaneous flapInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-11-2020
14:31:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/17/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-11-2020
14:31:36ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841480
Page 127 of 210
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
Sep/17/2016
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841481
Page 128 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-11-2020
14:32:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-11-2020
14:32:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
75.6Initial Entry
3. Unit:
Date Location User Value Reason
Sep-11-2020
14:32:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841482
Page 129 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-11-2020
14:32:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
176.78Initial Entry
5. Unit:
Date Location User Value Reason
Sep-11-2020
14:32:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-11-2020
14:32:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24.2Initial Entry
7.a
Date Location User Value Reason
Sep-11-2020
14:32:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Record Ide
ntifier::1
Temperatu
re:97.3Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841483
Page 130 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-11-2020
14:32:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-11-2020
14:32:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
97.3Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-11-2020
14:32:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
FInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841484
Page 131 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7.a Temperature Location:
Date Location User Value Reason
Sep-11-2020
14:32:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841485
Page 132 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-11-2020
14:33:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-11-2020
14:33:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
86980Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841486
Page 133 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020
17:42:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020
17:42:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020
17:42:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-11-2020
17:42:05
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841487
Page 134 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-11-2020
17:42:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection
:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020
17:42:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BP18J
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020
17:42:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP18JZInitial Entry
5.b
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841488
Page 135 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-11-2020
17:42:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BPHS5
9Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-11-2020
17:42:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BPHS59Initial Entry
5.c
Date Location User Value Reason
Sep-11-2020
17:43:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BPHS5
BInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841489
Page 136 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Sep-11-2020
17:43:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BPHS5BInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841490
Page 137 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020
17:43:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020
17:43:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020
17:43:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-11-2020
17:43:07
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841491
Page 138 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-11-2020
17:43:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection
:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020
17:43:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BP18K
7Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020
17:43:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP18K7Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841492
Page 139 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-11-2020
14:33:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020
14:33:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-11-2020
14:33:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841493
Page 140 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-11-2020
14:33:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/11/2020 11:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020
14:33:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-11-2020
14:33:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-11-2020
14:33:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841494
Page 141 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-11-2020
14:33:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-11-2020
14:33:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841495
Page 142 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-11-2020
14:33:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841496
Page 143 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020
18:37:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/30/2020Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841497
Page 144 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-30-2020
18:38:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/30/2020Initial Entry
2.a
Date Location User Value Reason
Sep-30-2020
18:38:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Record Ide
ntifier::1
Temperatu
re:98.3
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-30-2020
18:38:45
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Hector
AguilarData Entry:
1Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841498
Page 145 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-30-2020
18:38:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-30-2020
18:38:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-30-2020
18:38:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841499
Page 146 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020
18:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020
18:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-30-2020
18:44:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-30-2020
18:44:42
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841500
Page 147 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-30-2020
18:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection
:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Sep-30-2020
18:44:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BP18V
2Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-30-2020
18:44:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP18V2Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841501
Page 148 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-30-2020
18:39:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-30-2020
18:39:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-30-2020
18:39:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841502
Page 149 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-30-2020
18:39:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/30/2020 16:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-30-2020
18:39:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-30-2020
18:39:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-30-2020
18:39:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841503
Page 150 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-30-2020
18:39:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-30-2020
18:39:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841504
Page 151 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-30-2020
16:48:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Oct/30/2020Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841505
Page 152 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020
17:50:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020
17:50:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020
17:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-30-2020
17:50:25
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841506
Page 153 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-30-2020
17:50:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection
:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-30-2020
17:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BR69S
2Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-30-2020
17:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BR69S2Initial Entry
5.b
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841507
Page 154 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-30-2020
17:55:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample I
D:BRZPW
3Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-30-2020
17:55:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BRZPW3Initial Entry
5.c
Date Location User Value Reason
Oct-30-2020
17:56:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample I
D:BRZPW
4Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841508
Page 155 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Oct-30-2020
17:56:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BRZPW4Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841509
Page 156 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-30-2020
09:43:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Dec-30-2020
09:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms
form is
missing.
Please review
and update as
appropriate.
Dec-30-2020
09:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of
Collection in
both Nasal
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841510
Page 157 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Swab Self and
Nasal Swab
are missing.
Please review
and update as
appropriate.
Dec-30-2020
09:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Dec/29/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-30-2020
09:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841511
Page 158 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Dec/29/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Dec/28/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-08-2021
15:11:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
Date of Last Symp
tom Resolved:
Jan/1/2021New
Information
Dec-30-2020
09:42:29ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841512
Page 159 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
4.a
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Symptoms: FEV
ER
Symptom Pr
esent:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
4.b
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841513
Page 160 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sympt
oms:NEW OR I
NCREASE
D COUGH
Sympt
om Pre
sent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NEW OR INCREAS
ED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Dec-30-2020 ACV0PFEINFP6000  Hector Data Entry: Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841514
Page 161 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)Aguilar Symp
toms:NEW OR IN
CREASED S
HORTNESS
OF BREATH
Symp
tom
Prese
nt:NO
4.c Symptoms:
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NEW OR INCREAS
ED SHORTNESS O
F BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Dec-30-2020
09:42:29ACV0PFEINFP6000  Hector
AguilarData Entry:
Symptoms: CHILInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841515
Page 162 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)LS
Symptom Pr
esent:NO
4.d Symptoms:
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE P
AINInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841516
Page 163 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sympt
om Pr
esent:NO
4.e Symptoms:
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NEW OR INCREAS
ED MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pr
esent:NOInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841517
Page 164 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.f Symptoms:
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NEW LOSS OF TAS
TE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Symp
toms:NEW OR IN
CREASED
SORE THR
OAT
Symp
tom P
resent
:NOInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841518
Page 165 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.g Symptoms:
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NEW OR INCREAS
ED SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Symptoms
:DIARR
HEA
Symptom
Present:NOInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841519
Page 166 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.h Symptoms:
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Symptoms
:VOMI
TING
Symptom
Present:YESInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841520
Page 167 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.i Symptoms:
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Dec-30-2020
09:42:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841521
Page 168 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Dec-30-2020
09:42:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
2. Specimen Type:
Date Location User Value Reason
Dec-30-2020
09:42:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Dec-30-2020
09:42:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841522
Page 169 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Dec-30-2020
09:42:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
5. Device Type:
Date Location User Value Reason
Dec-30-2020
09:42:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
6. Trade Name:
Date Location User Value Reason
Dec-30-2020
09:42:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
7. Test Result:
Date Location User Value Reason
Dec-30-2020
09:42:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841523
Page 170 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
8. Comments/Findings/Details:
Date Location User Value Reason
Dec-30-2020
09:42:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Dec-30-2020
09:42:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841524
Page 171 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-30-2020
09:43:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-30-2020
09:43:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-30-2020
09:43:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841525
Page 172 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Dec-30-2020
09:43:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
SWAB PFEInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841526
Page 173 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-30-2020
09:43:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-30-2020
09:43:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-30-2020
09:53:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-30-2020
09:43:17
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841527
Page 174 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Dec-30-2020
09:43:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection
:
Dec/29/2020Initial Entry
5.a
Date Location User Value Reason
Dec-30-2020
09:53:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample I
D:BR3NG
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-30-2020
09:53:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BR3NGVInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841528
Page 175 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Type of Prac
titioner:SPEC
IALI
ST
Occurrence
of Visits or C
ontacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841529
Page 176 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Type of Pr
actitioner:EMER
GENC
Y ROO
M
Occurrenc
e of Visits
or Contact
s:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
1.c
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841530
Page 177 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Type of P
ractitione
r:PRIMAR
Y CARE
PHYSICI
AN
Occurren
ce of Visi
ts or Con
tacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
PRIMARY CARE P
HYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841531
Page 178 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Type of Pra
ctitioner:URGE
NT C
ARE
Occurrence
of Visits or
Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)ACV0PFEINFP6000  Hector
AguilarData Entry:
Type of P
ractitioneTELEPH
ONE COInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841532
Page 179 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)r: NSULTA
TION
Occurren
ce of Visi
ts or Con
tacts:NO
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
TELEPHONE CON
SULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Hector
AguilarData Entry:
Type of Practi
tioner:OT
HE
RInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841533
Page 180 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada) Occurrence of
Visits or Cont
acts:NO
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Dec-30-2020
09:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841534
Page 181 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Dec-30-2020
09:43:39
(UTC-05:00)
Eastern 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
Dec-30-2020
09:43:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Dec-30-2020
09:43:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
1Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841535
Page 182 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ILLNESS DETAILS - SEVERE - eCRF Audit
Trail History
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Jan-08-2021
15:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
2. Subcategory of Clinical Event:
Date Location User Value Reason
Jan-08-2021
15:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
3. Was a diagnosis obtained?
Date Location User Value Reason
Jan-08-2021
15:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
4. Toxicity Grade:
Date Location User Value Reason
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841536
Page 183 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/29/2020Form: ILLNESS DETAILS - SEVERE - eCRF Audit
Trail History
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Jan-08-2021
15:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841537
Page 184 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/26/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-26-2021
16:28:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Jan/26/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-26-2021
16:28:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
COVID_A1Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841538
Page 185 of 210
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/26/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-26-2021
16:29:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-26-2021
16:29:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021
11:23:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-26-2021
16:29:00
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841539
Page 186 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/26/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-26-2021
16:29:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection
:
Jan/26/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021
11:23:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BR38V
3Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-27-2021
11:23:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BR38V3Initial Entry
5.b
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841540
Page 187 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/26/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Jan-27-2021
11:27:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BS60G
DInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-27-2021
11:27:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BS60GDInitial Entry
5.c
Date Location User Value Reason
Jan-27-2021
11:28:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BS60G
CInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841541
Page 188 of 210
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/26/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Jan-27-2021
11:28:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BS60GCInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841542
Page 189 of 210
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-30-2020
16:47:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Oct/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-30-2020
16:47:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-30-2020
16:47:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
COMPLETEDInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841543
Page 190 of 210
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021
12:32:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Feb/22/2021Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841544
Page 191 of 210
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-23-2021
12:32:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-23-2021
12:32:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-23-2021
12:32:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Participant is willin
g to return for Vacc
ination 3
Participant is:
eligible per loca
l/national recom
mendations and
confirmed to haInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841545
Page 192 of 210
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
ve received only
placebo at Vacci
nation 1/2
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841546
Page 193 of 210
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-23-2021
12:32:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Feb/22/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-23-2021
12:32:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841547
Page 194 of 210
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021
17:40:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Feb/25/2021Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841548
Page 195 of 210
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-25-2021
17:41:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
OBTAINED
Date Written Conse
nt Obtained
Feb/25/2021Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841549
Page 196 of 210
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-25-2021
17:41:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Feb/25/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-25-2021
17:41:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Feb-25-2021
17:41:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
COMPLETEDInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841550
Page 197 of 210
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-25-2021
17:41:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-25-2021
17:41:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021
11:27:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-26-2021
06:08:25
(UTC-05:00)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0841551
Page 198 of 210
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-25-2021
17:41:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-25-2021
17:41:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection
:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021
11:27:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BRLYB
2Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841552
Page 199 of 210
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-26-2021
11:27:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BRLYB2Initial Entry
5.b
Date Location User Value Reason
Feb-26-2021
11:46:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BS2F7
BInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-26-2021
11:46:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BS2F7BInitial Entry
5.c
Date Location User Value Reason
Feb-26-2021
11:46:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BS2F7
9Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841553
Page 200 of 210
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Feb-26-2021
11:46:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BS2F79Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841554
Page 201 of 210
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-25-2021
17:42:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-25-2021
17:42:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021
11:52:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-26-2021
06:08:25
(UTC-05:00)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0841555
Page 202 of 210
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-25-2021
17:42:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-25-2021
17:42:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection
:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021
11:52:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample I
D:BRLYB
LInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841556
Page 203 of 210
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-26-2021
11:52:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BRLYBLInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841557
Page 204 of 210
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-25-2021
17:42:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-25-2021
17:42:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-25-2021
17:42:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841558
Page 205 of 210
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-25-2021
17:42:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Feb/25/2021 15:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-25-2021
17:42:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-25-2021
17:42:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-25-2021
17:42:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841559
Page 206 of 210
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
8. Actual Dose:
Date Location User Value Reason
Feb-25-2021
17:42:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-25-2021
17:42:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-25-2021
17:42:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-25-2021
17:42:24ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841560
Page 207 of 210
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841561
Page 208 of 210
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-30-2020
16:47:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-11-2020
14:33:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-11-2020
14:27:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-30-2020
16:47:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Initial Entry
Sep-11-2020
14:33:13ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/11/2020Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841562
Page 209 of 210
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
Sep-11-2020
14:27:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/11/2020Initial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841563
Page 210 of 210
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-03-2020
14:14:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Click Here to EnableInitial Entry
090177e196ae30bb\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841564