125742 S1 M5 CRF c4591001 1156 11561044

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
418
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 418
***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: 11561044 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
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840809
Page 2 of 418
***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: 11561044 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
Aug/27/2020
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840810
Page 3 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11561044]
2.Birth Date: /1957
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840811
Page 4 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840812
Page 5 of 418
***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: 11561044 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
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840813
Page 6 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840814
Page 7 of 418
***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: 11561044 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:[hypertension]
Start Date: UNK/UNK/2002
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetes Mellitus Type 2]
Start Date: Feb/25/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[mild anxiety depression]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chronic obstructive pulmonary disease]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840815
Page 8 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[fatty liver]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840816
Page 9 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [87.05]
3.Unit: kg
4.Height: [167.5]
5.Unit: cm
6.Body Mass Index: [31.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840817
Page 10 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [242969]
3.Randomization Group: [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840818
Page 11 of 418
***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: 11561044 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:
Aug/27/2020
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 [BP188W]
5.bSample ID [BP188X]
5.cSample ID [BP188Y]
5.dSample ID [BPHRZJ]
5.eSample ID [BPHRZK]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840819
Page 12 of 418
***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: 11561044 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:
Aug/27/2020
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 [BP189G]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840820
Page 13 of 418
***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: 11561044 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: Aug/27/2020 11:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840821
Page 14 of 418
***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: 11561044 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
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840822
Page 15 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840823
Page 16 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Oct/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840824
Page 17 of 418
***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: 11561044 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:
Oct/9/2020
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 [BR2Z0V]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840825
Page 18 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?Not Done Comments
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840826
Page 19 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840827
Page 20 of 418
***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: 11561044 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:
Nov/6/2020
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 [BR69VW]
5.bSample ID [BRZPYH]
5.cSample ID [BRZPYJ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840828
Page 21 of 418
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840829
Page 22 of 418
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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 [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840830
Page 23 of 418
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840831
Page 24 of 418
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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 [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840832
Page 25 of 418
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840833
Page 26 of 418
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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 [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840834
Page 27 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840835
Page 28 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/2/2020
2.Date of First Symptom Started: Sep/1/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/29/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840836
Page 29 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840837
Page 30 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Sep/3/202
0 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
 2.Sep/8/202
0 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
 3.Sep/9/202
0 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
 4.Sep/14/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
 5.Sep/15/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840838
Page 31 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/3/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: LABCORP COVID-19 RT-PCR TEST
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840839
Page 32 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/8/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: THERMOFISHER APPL BIO TAQPATH COVID-19 COMBO KIT
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840840
Page 33 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/9/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: THERMOFISHER APPL BIO TAQPATH COVID-19 COMBO KIT
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840841
Page 34 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/14/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: THERMOFISHER APPL BIO TAQPATH COVID-19 COMBO KIT
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840842
Page 35 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/15/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: THERMOFISHER APPL BIO TAQPATH COVID-19 COMBO KIT
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840843
Page 36 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 11561044 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 COLLECTED ON-SITE USING SUBJECT'S SELF-SWAB KIT]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW90537 ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840844
Page 37 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 11561044 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/3/2020
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 [RW90537]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840845
Page 38 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: HEALTH CARE UTILIZATION
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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: YES
Number of Visits or Contacts:
[1]
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[5]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840846
Page 39 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: HEALTH CARE UTILIZATION
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
YES
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840847
Page 40 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Sep/5/2020  NO
Discharge Date:
Sep/19/2020
 Repeating Pages
 2.HOSPITALIZATION STATUS  ICU  Sep/5/2020  NO
Discharge Date:
Sep/19/2020
 Repeating Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840848
Page 41 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: HOSPITALIZATION DETAILS
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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Sep/5/2020
4.Ongoing? NO
Discharge Date:
Sep/19/2020
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840849
Page 42 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: HOSPITALIZATION DETAILS
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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: ICU
3.Admission Date: Sep/5/2020
4.Ongoing? NO
Discharge Date:
Sep/19/2020
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840850
Page 43 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment I
dentifierCon Non-Drug Treatme
nts Pre-specifiedTreatment TreatmentStart D
ateForm Instan
ce
 1.1  YES  HIGH FLOW OXYGE
N THERAPY HIGH FLOW OXYGE
N THERAPY Sep/5/2
020 Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840851
Page 44 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: HIGH FLOW OXYGEN THERAPY
4.Treatment: [HIGH FLOW OXYGEN THERAPY]
5.Start Date: Sep/5/2020
6.Ongoing? NO
End Date:
Sep/9/2020
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840852
Page 45 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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?YES
Respiratory Illness Diagnosis:
[COVID-19 PNEUMONIA]
Date of Diagnosis:
Sep/5/2020
3.Toxicity Grade: 4
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840853
Page 46 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical
Event:Subcategory of Clinical Event Diagnosis ObtainedToxicity G
radeForm Instanc
e
 1.SEVERE COVID-19
ILLNESS SIGNIFICANT ACUTE RENAL D
YSFUNCTION YES
Diagnosis:
ACUTE RENAL AZO
TEMIA
Start Date:
Sep/3/2020
Ongoing?:
YES
 2  Repeating
Pages
 2.SEVERE COVID-19
ILLNESS SIGNIFICANT ACUTE HEPATIC
DYSFUNCTION YES
Diagnosis:
ACUTE LIVER DYSF
UNCTION
Start Date:
Sep/3/2020
Ongoing?:
NO
End Date:
Sep/9/2020
 2  Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840854
Page 47 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Illness Details
1.Category of Clinical Event: SEVERE COVID-19 ILLNESS
2.Subcategory of Clinical Event: SIGNIFICANT ACUTE RENAL DYSFUNCTION
3.Was a diagnosis obtained? YES
Diagnosis:
[ACUTE RENAL AZOTEMIA]
Start Date:
Sep/3/2020
Ongoing?:
YES
4.Toxicity Grade: 2
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840855
Page 48 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Illness Details
1.Category of Clinical Event: SEVERE COVID-19 ILLNESS
2.Subcategory of Clinical Event: SIGNIFICANT ACUTE HEPATIC DYSFUNCTION
3.Was a diagnosis obtained? YES
Diagnosis:
[ACUTE LIVER DYSFUNCTION]
Start Date:
Sep/3/2020
Ongoing?:
NO
End Date:
Sep/9/2020
4.Toxicity Grade: 2
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840856
Page 49 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category f
or Lab TestVendor NameCollect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
 1.CLINICAL
CHEMIST
RY Finlay Clinical Laboratory 330
SW 27th Ave Ste # 101 Miami
, FL 33135 Sep/5/2
020 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
329  C Reactive Pro
tein_PX329 0.8 
30  Alanine Amin
otransferase_P
X30 156
 
28  Aspartate Ami
notransferase_
PX28 153
 
35  Alkaline Phos
phatase_PX35 89 
21  Bilirubin_PX2
1 0.3 
47  Blood Urea Ni
trogen_PX47 32 
48  Creatinine_PX
48 1.4 Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840857
Page 50 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category fo
r Lab TestVendor NameCollecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 2.CLINICAL
CHEMISTR
Y LabCorp Tampa 5610 W La
Salle Street Tampa FL 3360
71770 Sep/3/2
020 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
329  C Reactive Prot
ein_PX329 [ ] 
30  Alanine Amino
transferase_PX
30 171
 
28  Aspartate Amin
otransferase_P
X28 193
 
35  Alkaline Phosp
hatase_PX35 72 
21  Bilirubin_PX21
 0.6 
47  Blood Urea Nit
rogen_PX47 30 
48  Creatinine_PX4
8 1.5
8 Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840858
Page 51 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Finlay Clinical Laboratory 330 SW 27th Ave Ste # 101 Miami, FL 33135]
3.Collection Date: Sep/5/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [0.8]
Not Done:
LNMT Low
[0.0]
High
[0.9]
Unit
mg/dL
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [156]
Not Done:
LNMT Low
[14]
High
[63]
Unit
U/L
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840859
Page 52 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [153]
Not Done:
LNMT Low
[15]
High
[37]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [89]
Not Done:
LNMT Low
[46]
High
[116]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.3]
Not Done:
LNMT Low
[0.4]
High
[0.8]
Unit
mg/dL
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840860
Page 53 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [32]
Not Done:
LNMT Low
[7]
High
[18]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.4]
Not Done:
LNMT Low
[0.6]
High
[1.3]
Unit
mg/dL
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840861
Page 54 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [LabCorp Tampa 5610 W LaSalle Street Tampa FL 336071770]
3.Collection Date: Sep/3/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [171]
Not Done:
LNMT Low
[0]
High
[44]
Unit
U/L
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840862
Page 55 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [193]
Not Done:
LNMT Low
[0]
High
[40]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [72]
Not Done:
LNMT Low
[39]
High
[117]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.6]
Not Done:
LNMT Low
[0.0]
High
[1.2]
Unit
mg/dL
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840863
Page 56 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [30]
Not Done:
LNMT Low
[8]
High
[27]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.58]
Not Done:
LNMT Low
[0.76]
High
[1.27]
Unit
mg/dL
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840864
Page 57 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category f
or Lab Tes
tVendor Name (DERIVED)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.HEMATO
LOGY Finlay Clinical Laboratory 330 S
W 27th Ave Ste # 101 Miami, FL
33135 Sep/5/2
020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
1  Hemoglob
in_PX1 15.
4 
2  Hematocri
t_PX2 46.
2 
3  Erythrocyt
es_PX3 5.1
4 
5  Platelets_
PX5 186
 
7  Leukocyte
s_PX7 6.3 
608  Neutrophil
s_PX608 75.
9 
609  Eosinophil
s_PX609 0.1 
612  Monocyte
s_PX612 9.0 
610  Basophils
_PX610 0.3 
611  Lymphocy
tes_PX611
 14.
7 Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840865
Page 58 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Finlay Clinical Laboratory 330 SW 27th Ave Ste # 101 Miami, FL 33135]
3.Collection Date: Sep/5/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [15.4]
Not Done:
LNMT Low
[14.00]
High
[18.00]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [46.2]
Not Done:
LNMT Low
[42]
High
[52]
Unit
%
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840866
Page 59 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [5.14]
Not Done:
LNMT Low
[4.70]
High
[6.10]
Unit
10^6/cu mm
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [186]
Not Done:
LNMT Low
[130]
High
[400]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [6.3]
Not Done:
LNMT Low
[4.8]
High
[10.8]
Unit
10^3/uL
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840867
Page 60 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [75.9]
Not Done:
LNMT Low
[47.0]
High
[75.0]
Unit
%
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.1]
Not Done:
LNMT Low
[0.0]
High
[6.0]
Unit
%
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [9.0]
Not Done:
LNMT Low
[0.0]
High
[11.0]
Unit
%
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840868
Page 61 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.3]
Not Done:
LNMT Low
[0.0]
High
[3.0]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [14.7]
Not Done:
LNMT Low
[18.0]
High
[46.0]
Unit
%
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840869
Page 62 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840870
Page 63 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840871
Page 64 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Date: Vital Signs Details Form Instance
 1.Sep/5/2020 Record Identifier: Oxygen Saturation
1  88.0 Repeating Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840872
Page 65 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Date: Vital Signs Details Form Instance
 2.Sep/14/2020 Record Identifier: Oxygen Saturation
1  84.0 Repeating Pages
 3.Sep/29/2020 Record Identifier: Oxygen Saturation
1  89.0 Repeating Pages
 4.Oct/1/2020 Record Identifier: Oxygen Saturation
1  92.0 Repeating Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840873
Page 66 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/5/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [88.0]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840874
Page 67 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/14/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [84.0]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840875
Page 68 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/29/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [89.0]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840876
Page 69 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/1/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [92.0]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840877
Page 70 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840878
Page 71 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840879
Page 72 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840880
Page 73 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840881
Page 74 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of
Assess
mentLocation
of Assess
mentImagin
g Meth
odOverall AssessmentForm Insta
nce
 1.Sep/8/2
020 CHEST  X-RAY
 ABNORMAL
If abnormal, specify findings:
Bibasilar mixed infiltrates, greater to the LEFT. Mild overinflation m
ild, chronic appearing diffuse interstitial prominence.
 Repeating
Pages
 2.Sep/12/
2020 CHEST  X-RAY
 ABNORMAL
If abnormal, specify findings:
Scattered alveolar interstitial changes are seen in the perihilar region
and at the lung bases. Findings are consistent with atypical infiltrates
.
 Repeating
Pages
 3.Sep/5/2
020 CHEST  X-RAY
 ABNORMAL
If abnormal, specify findings:
Bibasilar diffuse mixed infiltrates. No focal infiltrates, effusions or p
neumothoraces. Mild overinflation, chronic appearing diffuse intersti
tial prominence.
 Repeating
Pages
 4.Sep/14/
2020 CHEST  X-RAY
 ABNORMAL
If abnormal, specify findings:
There are bilateral interstitial infiltrates within both lungs. Interval i
mprovement is observed. No alveolar consolidation or pleural effusio
n is noted. No acute osseous abnormality is detected.
 Repeating
Pages
 5.Sep/30/
2020 CHEST  X-RAY
 ABNORMAL
If abnormal, specify findings:
Chronic interstitial fibrosis in lungs, especially on right side with sug
gestion of patchy infiltrates in both lower lobes, especially on the left
side. No evidence of pleural effusions.
 Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840882
Page 75 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/8/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Bibasilar mixed infiltrates, greater to the LEFT. Mild overinflation mild,
chronic appearing diffuse interstitial prominence.]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840883
Page 76 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/12/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Scattered alveolar interstitial changes are seen in the perihilar region and at
the lung bases. Findings are consistent with atypical infiltrates.]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840884
Page 77 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/5/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Bibasilar diffuse mixed infiltrates. No focal infiltrates, effusions or
pneumothoraces. Mild overinflation, chronic appearing diffuse interstitial
prominence.]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840885
Page 78 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/14/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[There are bilateral interstitial infiltrates within both lungs. Interval
improvement is observed. No alveolar consolidation or pleural effusion is
noted. No acute osseous abnormality is detected.]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840886
Page 79 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/30/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Chronic interstitial fibrosis in lungs, especially on right side with suggestion
of patchy infiltrates in both lower lobes, especially on the left side. No
evidence of pleural effusions.]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840887
Page 80 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840888
Page 81 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Mar/5/2021
2.Date of First Symptom Started: Mar/4/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840889
Page 82 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.Symptoms - Other Text: [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840890
Page 83 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Collect
ionSpecimen T
ypeSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Type Form Instance
 1.Not Applicable  Not Applicab
le Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840891
Page 84 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 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
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840892
Page 85 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 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 [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840893
Page 86 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 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:
Mar/5/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRLYG6]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840894
Page 87 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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
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
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840895
Page 88 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.        Repeating Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840896
Page 89 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Hospitalization Details
1.Hospitalization Category:
2.Hospitalization Term:
3.Admission Date: //
4.Ongoing?
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840897
Page 90 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840898
Page 91 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 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?
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840899
Page 92 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 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
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840900
Page 93 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical Event
:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840901
Page 94 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840902
Page 95 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840903
Page 96 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 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
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840904
Page 97 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840905
Page 98 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 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
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840906
Page 99 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840907
Page 100 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 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: [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840908
Page 101 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840909
Page 102 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 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 % [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840910
Page 103 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840911
Page 104 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 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): [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840912
Page 105 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840913
Page 106 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 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?
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840914
Page 107 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840915
Page 108 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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:
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840916
Page 109 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/01/2020Form: 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840917
Page 110 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/01/2020Form: 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: 11561044 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/5/2020
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 [BR2YYS]
5.bSample ID [BPHRLS]
5.cSample ID [BPHRLT]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840918
Page 111 of 418
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840919
Page 112 of 418
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840920
Page 113 of 418
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Sep/8/2020
2.Phase of Disposition: VACCINATION
3.Status: NO LONGER MEETS ELIGIBILITY CRITERIA
4.Specify Status: [EXCLUSION CRITERIA #5]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840921
Page 114 of 418
***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: 11561044 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: [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840922
Page 115 of 418
***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: 11561044 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:
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840923
Page 116 of 418
***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: 11561044 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 [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840924
Page 117 of 418
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1. DELETED ADVERSE
EVENT 1  ACUTE VIRAL BR
ONCHITIS Sep/1/2020 U
NK:UNK YES  Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840925
Page 118 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ACUTE VIRAL BRONCHITIS ]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNRELATED NEW MEDICAL CONDITION/POSSIBLE COVID-19 ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840926
Page 119 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840927
Page 120 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840928
Page 121 of 418
***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: 11561044 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[ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840929
Page 122 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840930
Page 123 of 418
***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: 11561044 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: //
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840931
Page 124 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1. DELETED           Repeating
Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840932
Page 125 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ] Comments
2.Category: Comments
3.Concomitant Medications
Pre-specified:Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ] Comments
5.Dose: [ ] Comments
6.Dose Unit: Comments
7.Dose Frequency: Comments
8.Route: Comments
9.Start Date: // Comments
10.Ongoing? Comments
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840933
Page 126 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840934
Page 127 of 418
***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: 11561044 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?
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840935
Page 128 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840936
Page 129 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840937
Page 130 of 418
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840938
Page 131 of 418
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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:
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840939
Page 132 of 418
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled 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: 11561044 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?
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840940
Page 133 of 418
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840941
Page 134 of 418
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840942
Page 135 of 418
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840943
Page 136 of 418
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840944
Page 137 of 418
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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 [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840945
Page 138 of 418
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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 [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840946
Page 139 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840947
Page 140 of 418
***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: 11561044 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
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840948
Page 141 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840949
Page 142 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840950
Page 143 of 418
***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: 11561044 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: [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840951
Page 144 of 418
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840952
Page 145 of 418
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840953
Page 146 of 418
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840954
Page 147 of 418
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840955
Page 148 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/8/2020
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840956
Page 149 of 418
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840957
Page 150 of 418
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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-08-2021 14:53:14 (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.
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840958
Page 151 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormAug-27-2020 14:00:51 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840959
Page 152 of 418
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-09-2020 17:30:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Done
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840960
Page 153 of 418
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-09-2020 17:30:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Done
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840961
Page 154 of 418
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Oct-09-2020 17:30:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Done
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840962
Page 155 of 418
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Oct-09-2020 17:30:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Done
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840963
Page 156 of 418
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Oct-09-2020 17:30:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Done
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840964
Page 157 of 418
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Oct-09-2020 17:30:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Done
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840965
Page 158 of 418
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Oct-09-2020 17:30:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Done
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840966
Page 159 of 418
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
7Oct-09-2020 17:30:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Done
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840967
Page 160 of 418
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
8Oct-09-2020 17:30:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Done
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840968
Page 161 of 418
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
9Oct-09-2020 17:30:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Done
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840969
Page 162 of 418
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
10Oct-09-2020 17:30:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Done
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840970
Page 163 of 418
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
11Oct-09-2020 17:30:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Done
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840971
Page 164 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-28-2020 16:46:07 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840972
Page 165 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Sep-28-2020 16:46:07 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840973
Page 166 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aSep-28-2020 16:46:07 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840974
Page 167 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aSep-28-2020 16:46:07 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840975
Page 168 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aSep-28-2020 16:46:07 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840976
Page 169 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aSep-28-2020 16:46:07 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840977
Page 170 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-28-2020 16:07:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840978
Page 171 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Sep-28-2020 16:07:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840979
Page 172 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Sep-28-2020 16:07:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840980
Page 173 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Sep-28-2020 16:07:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840981
Page 174 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-28-2020 14:30:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840982
Page 175 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Sep-28-2020 14:30:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840983
Page 176 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Sep-28-2020 14:30:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840984
Page 177 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Sep-28-2020 14:30:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840985
Page 178 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Sep-28-2020 14:30:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840986
Page 179 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Sep-28-2020 14:30:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840987
Page 180 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Sep-28-2020 14:30:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840988
Page 181 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-05-2021 14:42:57 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840989
Page 182 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-05-2021 14:42:57 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840990
Page 183 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Mar-05-2021 14:42:57 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840991
Page 184 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Mar-05-2021 14:42:57 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840992
Page 185 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Mar-05-2021 14:42:57 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840993
Page 186 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Mar-05-2021 14:42:57 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840994
Page 187 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Mar-05-2021 14:42:57 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840995
Page 188 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
7Mar-05-2021 14:42:57 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840996
Page 189 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
8Mar-05-2021 14:42:57 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840997
Page 190 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/05/2021Form: 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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
9Mar-05-2021 14:42:57 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840998
Page 191 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormSep-15-2020 12:27:06 (UTC-05:00) Eastern
Time (US & Canada)
FormSep-14-2020 16:16:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840999
Page 192 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Sep-15-2020 12:27:06 (UTC-05:00) Eastern
Time (US & Canada)
1Sep-14-2020 16:16:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841000
Page 193 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Sep-15-2020 12:27:06 (UTC-05:00) Eastern
Time (US & Canada)
2Sep-14-2020 16:16:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841001
Page 194 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
3Sep-15-2020 12:27:06 (UTC-05:00) Eastern
Time (US & Canada)
3Sep-14-2020 16:16:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841002
Page 195 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Sep-15-2020 12:27:06 (UTC-05:00) Eastern
Time (US & Canada)
4Sep-14-2020 16:16:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841003
Page 196 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5Sep-15-2020 12:27:06 (UTC-05:00) Eastern
Time (US & Canada)
5Sep-14-2020 16:16:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841004
Page 197 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
6Sep-15-2020 12:27:06 (UTC-05:00) Eastern
Time (US & Canada)
6Sep-14-2020 16:16:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841005
Page 198 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
7Sep-15-2020 12:27:06 (UTC-05:00) Eastern
Time (US & Canada)
7Sep-14-2020 16:16:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841006
Page 199 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
8Sep-15-2020 12:27:06 (UTC-05:00) Eastern
Time (US & Canada)
8Sep-14-2020 16:16:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841007
Page 200 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
9Sep-15-2020 12:27:06 (UTC-05:00) Eastern
Time (US & Canada)
9Sep-14-2020 16:16:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841008
Page 201 of 418
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
10Sep-15-2020 12:27:06 (UTC-05:00) Eastern
Time (US & Canada)
10Sep-14-2020 16:16:55 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841009
Page 202 of 418
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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-08-2021 14:53:14 (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 Mar-05-2021 14:40:16 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Feb-23-2021 14:14:23 (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 Feb-22-2021 10:19:16 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841010
Page 203 of 418
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Hector
Rodriguez Approved Feb-19-2021 12:44:00 (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 Feb-15-2021 11:46:17 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Nov-09-2020 13:49:03 (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 Nov-06-2020 15:48:44 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Oct-23-2020 17:04:04 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841011
Page 204 of 418
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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.
 N/A Oct-23-2020 12:21:57 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Oct-16-2020 17:56:34 (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.
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0841012
Page 205 of 418
***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: 11561044 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
Aug-27-2020 13:59:24
(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
Aug-27-2020 13:59:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841013
Page 206 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-27-2020 13:59:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
OBTAINED
Date Written Consent Obtained
Aug/27/2020Initial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841014
Page 207 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-27-2020 13:59:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11561044Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-27-2020 13:59:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1957Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020 13:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-27-2020 13:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-27-2020 13:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
WHITEInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841015
Page 208 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020 14:00:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/27/2020Initial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841016
Page 209 of 418
***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: 11561044 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
Aug-27-2020 14:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-27-2020 14:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020 14:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
COMPLETEDInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841017
Page 210 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Aug-27-2020 14:03:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:hypertension
Start Date: UNK/UNK/2
002
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-27-2020 14:03:27
(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
Aug-27-2020 14:03:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
hypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-27-2020 14:03:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
UNK/UNK/2002Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-27-2020 14:03:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841018
Page 211 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b
Date Location User Value Reason
Aug-27-2020 15:39:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Diabetes Mellitu
s Type 2
Start Date: Feb/25/2020
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-27-2020 15:39:05
(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
Aug-27-2020 15:39:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Diabetes Mellitus Type 2Initial Entry
1.b Start Date:
Date Location User Value Reason
Aug-27-2020 15:39:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Feb/25/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-27-2020 15:39:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841019
Page 212 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-27-2020 15:46:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:mild anxiety de
pression
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-27-2020 15:46:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 15:46:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
mild anxiety depressionInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-27-2020 15:46:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-27-2020 15:46:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-27-2020 15:48:40
(UTC-05:00) EasternACV0PFEINFP6000  Hector
AguilarData Entry:
Line/MH N 4Transcription Error
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841020
Page 213 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada) umber:
Medical Hi
story Term:chronic obstructiv
e pulmonary disea
se
Start Date: UNK/UNK/2018
Ongoing: YES
Aug-27-2020 15:47:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:obstructive pulm
onary disease
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841021
Page 214 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.d Line/MH Number:
Date Location User Value Reason
Aug-27-2020 15:47:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 15:48:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
chronic obstructive pulmonary d
iseaseTranscription Error
Aug-27-2020 15:47:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
obstructive pulmonary diseaseInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-27-2020 15:47:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-27-2020 15:47:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-27-2020 15:48:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:fatty liver
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841022
Page 215 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.e Line/MH Number:
Date Location User Value Reason
Aug-27-2020 15:48:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 15:48:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
fatty liverInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-27-2020 15:48:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-27-2020 15:48:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841023
Page 216 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020 14:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-27-2020 15:49:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-27-2020 15:49:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
87.05Transcription Error
Aug-27-2020 14:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Weight 167.5 is
outside of Normal
Range 25 - 136 for
kg or 50 - 300 for
lb.
Aug-27-2020 14:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
167.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-27-2020 14:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-27-2020 15:49:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841024
Page 217 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-27-2020 15:49:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
167.5Transcription Error
Aug-27-2020 14:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Height 87.05 is
outside of Normal
Range 140 - 198 for
cm or 55 - 80 for in.
Aug-27-2020 14:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
87.05Initial Entry
5. Unit:
Date Location User Value Reason
Aug-27-2020 14:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-27-2020 15:49:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31.0Transcription Error
Aug-27-2020 15:49:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
114.9Transcription Error
Aug-27-2020 14:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
221.0Initial Entry
7.a
Date Location User Value Reason
Aug-27-2020 14:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Record Identifier:
:1
Temperature: 98.3
Temperature Unit
:FInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841025
Page 218 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Temperature Loc
ation::ORAL CAV
ITY
7.a Record Identifier:
Date Location User Value Reason
Aug-27-2020 14:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-27-2020 14:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-27-2020 14:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-27-2020 14:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841026
Page 219 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-27-2020 14:04:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-27-2020 14:04:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
242969Initial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841027
Page 220 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 16:32:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 16:32:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 16:33:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 16:32:17
(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.
Aug-27-2020 16:32:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 16:33:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BP188WInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841028
Page 221 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 16:33:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP188WInitial Entry
5.b
Date Location User Value Reason
Aug-27-2020 16:33:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BP188XInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-27-2020 16:33:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP188XInitial Entry
5.c
Date Location User Value Reason
Aug-27-2020 16:33:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BP188YInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-27-2020 16:33:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP188YInitial Entry
5.d
Date Location User Value Reason
Aug-27-2020 16:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BPHRZJInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841029
Page 222 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.d Sample ID
Date Location User Value Reason
Aug-27-2020 16:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BPHRZJInitial Entry
5.e
Date Location User Value Reason
Aug-27-2020 16:34:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BPHRZKInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-27-2020 16:34:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BPHRZKInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841030
Page 223 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 16:34:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 16:34:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 16:34:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 16:34:37
(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.
Aug-27-2020 16:34:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 16:34:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BP189GInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841031
Page 224 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 16:34:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP189GInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841032
Page 225 of 418
***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: 11561044 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
Aug-27-2020 14:06:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020 14:06:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020 14:06:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-27-2020 14:06:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/27/2020 11:52Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020 14:06:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-27-2020 14:06:34
(UTC-05:00) EasternACV0PFEINFP6000  Hector
AguilarData Entry:
LEFTInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841033
Page 226 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-27-2020 14:06:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-27-2020 14:06:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-27-2020 14:06:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841034
Page 227 of 418
***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: 11561044 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
Aug-27-2020 14:06:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841035
Page 228 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User ValueReason
Oct-13-2020
02:18:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedAs per site
confirmation -
updated PD tracker
Oct-12-2020
17:16:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Hector Aguilar Query
1: An
swere
dsubject was out of
window for V2
Oct-12-2020
16:34:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V2_VAX2_L is out
of window for 20
days from
V1_DAY1_VAX1_L
Dose Date. Please
verify and update.
Oct-09-2020
17:30:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Hector Aguilar Data
Entry
:
Oct/9/
2020Initial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841036
Page 229 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Oct-09-2020 17:30:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Oct/9/2020Initial Entry
2.a
Date Location User Value Reason
Oct-09-2020 17:30:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Record Identifier:
:1
Temperature: 98.3
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-09-2020 17:30:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-09-2020 17:30:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-09-2020 17:30:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
FInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841037
Page 230 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.a Temperature Location:
Date Location User Value Reason
Oct-09-2020 17:30:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841038
Page 231 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-09-2020 17:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-09-2020 17:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-09-2020 17:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-09-2020 17:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-09-2020 17:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection:
Oct/9/2020Initial Entry
5.a
Date Location User Value Reason
Oct-09-2020 17:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BR2Z0VInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841039
Page 232 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Oct-09-2020 17:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BR2Z0VInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841040
Page 233 of 418
***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: 11561044 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
Oct-09-2020 17:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-09-2020 17:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-09-2020 17:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-09-2020 17:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-09-2020 17:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-09-2020 17:30:55
(UTC-05:00) EasternACV0PFEINFP6000  Hector
AguilarData Entry:
Not DoneInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841041
Page 234 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-09-2020 17:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Oct-09-2020 17:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Oct-09-2020 17:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-09-2020 17:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-09-2020 17:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not DoneInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841042
Page 235 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020 15:48:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Nov/6/2020Initial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841043
Page 236 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-06-2020 16:47:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020 16:47:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020 16:47:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-06-2020 16:47:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-06-2020 16:47:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection:
Nov/6/2020Initial Entry
5.a
Date Location User Value Reason
Nov-06-2020 16:47:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BR69VWInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841044
Page 237 of 418
***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: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Nov-06-2020 16:47:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BR69VWInitial Entry
5.b
Date Location User Value Reason
Nov-06-2020 16:49:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BRZPYHInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-06-2020 16:49:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BRZPYHInitial Entry
5.c
Date Location User Value Reason
Nov-06-2020 16:50:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BRZPYJInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-06-2020 16:50:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BRZPYJInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841045
Page 238 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 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-02-2020 15:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Sep-30-2020 12:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered COMPLETE
Sep-10-2020 09:58:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened Clinical Query: ILL
POTEN form is
pending.
Sep-09-2020 11:37:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Deleted Close Auto Query
Sep-09-2020 11:36:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Candidate Date of Visit is
completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update as
appropriate.
Sep-09-2020 10:31:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered THEY ARE
ANSWERED
WHEN
INFORMATION IS
RECEIVED.
Sep-04-2020 16:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened Clinical Query: Per
CRF CRs Section
8.26, please
complete COVID
TEST and ILL
POTEN forms.
Sep-03-2020 18:33:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0841046
Page 239 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Sep-03-2020 18:29:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Transcription Error
Sep-03-2020 18:05:38
(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.
Sep-03-2020 18:05:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update as
appropriate.
Sep-03-2020 18:05:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Sep-03-2020 18:05:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0841047
Page 240 of 418
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-15-2021 19:33:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Feb-15-2021 11:46:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered New Information
Feb-15-2021 11:46:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
NO
Date of Last Symptom Resol
ved:
Sep/29/2020New Information
Feb-15-2021 09:19:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened Please confirm the
symptoms are still
ongoing for this
COVID Illness. If
all symptoms for
this illness are
resolved; please
update the Last
Symptoms
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841048
Page 241 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Resolved Date else
clarify.
Oct-29-2020 11:18:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Site has confirmed
symptoms ongoing
(i.e., sequelae);
clinical agrees
ongoing
Oct-28-2020 18:45:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered CRF CG DOES
NOT PROVIDE
GUIDANCE ON
COVID-19
ILLNESSES
WHICH CAUSE
SEQUELAE.
Oct-28-2020 09:51:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened DM Query:
Convalescent visit
occurred but Date
of Last Symptom
Resolved is
missing. Please
confirm symptoms
are still ongoing. If
symptoms have
resolved update
response for
Symptom ongoing
as 'No' and add date
resolved.
Oct-14-2020 14:04:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Per clinical - no
further response
needed at this time.
Symptoms ongoing
should remain as
Yes per site's
previous response
Oct-14-2020 08:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Thanks for the
response, However
If resolved, please
update response and
provide resolution
date.
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0841049
Page 242 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-12-2020 15:56:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered THE COVID-19
ILLNESS IS
RESOLVED WITH
SEQUELAE.
THERE IS NO
GUIDANCE ON
HOW TO ENTER
DATA FOR THIS
EVENT.
Oct-12-2020 15:53:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM Query:
Convalescent visit
has occurred.
Please confirm
symptoms are
ongoing. If
resolved, update
response and
provide resolution
date.
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Sep-03-2020 18:32:50 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0841050
Page 243 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00) Eastern
Time (US & Canada)YES
4.b
Date Location User Value Reason
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCRE
ASED COUGH
Symptom
Present:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUG
HInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREAS
ED SHORTNESS OF
BREATH
Sympto
m Prese
nt:YESInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0841051
Page 244 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.c Symptoms:
Date Location User Value Reason
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHOR
TNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Sep-28-2020 17:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: YESNew Information
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Sep-28-2020 17:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESNew Information
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30c2\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0841052
Page 245 of 418
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.e
Date Location User Value Reason
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREA
SED MUSCLE PAI
N
Symptom
Present:YESInitial Entry
4.e Symptoms:
Date Location User Value Reason
Sep-03-2020 18:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSC
LE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Sep-03-2020 18:32:50
(UTC-05:00)
…[truncated]
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