Document text
Page 1 of 128
***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: 11561124 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
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841227
Page 2 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/10/2020
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841228
Page 3 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11561124]
2.Birth Date: /1967
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0841229
Page 4 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841230
Page 5 of 128
***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: 11561124 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
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841231
Page 6 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841232
Page 7 of 128
***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: 11561124 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:[anxiety]
Start Date: Nov/UNK/2018
Ongoing: YES
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841233
Page 8 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
2.Weight: [98.1]
3.Unit: kg
4.Height: [181.2]
5.Unit: cm
6.Body Mass Index: [29.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841234
Page 9 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/10/2020
2.Randomization Number: [85827]
3.Randomization Group: [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841235
Page 10 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BP18JF]
5.bSample ID [BPHS4V]
5.cSample ID [BPHS4W]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841236
Page 11 of 128
***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: 11561124 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/10/2020
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 [BP18JM]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841237
Page 12 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/10/2020 12:16
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
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841238
Page 13 of 128
***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: 11561124 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
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841239
Page 14 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841240
Page 15 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Oct/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841241
Page 16 of 128
***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: 11561124 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/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR2YYJ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841242
Page 17 of 128
***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: 11561124 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: Oct/2/2020 10:39
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
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841243
Page 18 of 128
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841244
Page 19 of 128
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11561124 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 [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841245
Page 20 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841246
Page 21 of 128
***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: 11561124 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 [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841247
Page 22 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841248
Page 23 of 128
***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: 11561124 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 [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841249
Page 24 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841250
Page 25 of 128
***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: 11561124 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 [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841251
Page 26 of 128
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841252
Page 27 of 128
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841253
Page 28 of 128
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 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 [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841254
Page 29 of 128
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 11561124 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 [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841255
Page 30 of 128
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
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?
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841256
Page 31 of 128
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841257
Page 32 of 128
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841258
Page 33 of 128
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 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 [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841259
Page 34 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841260
Page 35 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841261
Page 36 of 128
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/2/2020
2.Phase of Disposition: VACCINATION
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841262
Page 37 of 128
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
:Nov/2/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841263
Page 38 of 128
***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: 11561124 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:
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841264
Page 39 of 128
***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: 11561124 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 [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841265
Page 40 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE E
VENT 1 RESPIRATORY ARRE
ST Nov/2/2020 UNK
:UNK NO
End Date Time:
Nov/2/2020 UNK:UNK
Repeating
Pages
2.ADVERSE E
VENT 2 MULTIPLE DRUG OV
ERDOSE Nov/2/2020 UNK
:UNK NO
End Date Time:
Nov/2/2020 UNK:UNK
Repeating
Pages
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841266
Page 41 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[RESPIRATORY ARREST]
4.Start Date Time: Nov/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/2/2020 UNK:UNK
6.Toxicity Grade: 4 Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841267
Page 42 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[DRUG OVERDOSE]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number:
For Pfizer Use Only[2020459412]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841268
Page 43 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[MULTIPLE DRUG OVERDOSE]
4.Start Date Time: Nov/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/2/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841269
Page 44 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[DRUG OVERDOSE]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number:
For Pfizer Use Only[2020459412]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841270
Page 45 of 128
***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: 11561124 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
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841271
Page 46 of 128
***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: 11561124 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[ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841272
Page 47 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841273
Page 48 of 128
***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: 11561124 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: //
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841274
Page 49 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841275
Page 50 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841276
Page 51 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841277
Page 52 of 128
***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: 11561124 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?
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841278
Page 53 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841279
Page 54 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841280
Page 55 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841281
Page 56 of 128
***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: 11561124 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:
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841282
Page 57 of 128
***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: 11561124 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?
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841283
Page 58 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841284
Page 59 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841285
Page 60 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841286
Page 61 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841287
Page 62 of 128
***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: 11561124 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 [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841288
Page 63 of 128
***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: 11561124 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 [ ]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841289
Page 64 of 128
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841290
Page 65 of 128
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841291
Page 66 of 128
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841292
Page 67 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841293
Page 68 of 128
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Nov/2/2020
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [RESPIRATORY ARREST]
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841294
Page 69 of 128
***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: 11561124 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 Nov/2/2020
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841295
Page 70 of 128
***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: 11561124 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
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841296
Page 71 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Hector
Rodriguez Approved Mar-04-2021 12:05:05 (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.
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841297
Page 72 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-10-2020 13:24:58 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841298
Page 73 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Nov-24-2020 16:03:13 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar
6Nov-23-2020 15:50:02 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841299
Page 74 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Hector
Rodriguez Approved Mar-04-2021 12:05:05 (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-01-2021 16:48:59 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Jan-23-2021 14:19:51 (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 Dec-23-2020 13:29:02 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841300
Page 75 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Hector
Rodriguez Approved Dec-01-2020 14:27:10 (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-25-2020 15:21:03 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Nov-25-2020 14:20:28 (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-24-2020 15:59:56 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Nov-23-2020 16:11:32 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841301
Page 76 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, HectorRodriguez, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Hector Aguilar N/A Nov-23-2020 15:49:49 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Nov-09-2020 16:11:36 (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.
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841302
Page 77 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-10-2020 13:23:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-10-2020 13:23:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841303
Page 78 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-10-2020 13:24:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
OBTAINED
Date Written Consent Obtained
Sep/10/2020Initial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841304
Page 79 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-10-2020 13:23:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11561124Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-10-2020 13:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1967Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-10-2020 13:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-10-2020 13:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-10-2020 13:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
WHITEInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841305
Page 80 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-10-2020 13:24:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sep/10/2020Initial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841306
Page 81 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-10-2020 13:25:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sep/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-10-2020 13:25:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-10-2020 13:25:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
COMPLETEDInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841307
Page 82 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Sep-10-2020 13:25:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:anxiety
Start Date: Nov/UNK/20
18
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-10-2020 13:25:40
(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
Sep-10-2020 13:25:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
anxietyInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-10-2020 13:25:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Nov/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-10-2020 13:25:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841308
Page 83 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020 13:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sep/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-10-2020 13:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
98.1Initial Entry
3. Unit:
Date Location User Value Reason
Sep-10-2020 13:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-10-2020 13:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
181.2Initial Entry
5. Unit:
Date Location User Value Reason
Sep-10-2020 13:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-10-2020 13:26:23
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.9Initial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841309
Page 84 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-10-2020 13:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Record Identifier:
:1
Temperature: 97.6
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-10-2020 13:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-10-2020 13:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
97.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-10-2020 13:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-10-2020 13:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841310
Page 85 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-10-2020 13:26:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sep/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-10-2020 13:26:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
85827Initial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841311
Page 86 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 17:01:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 17:01:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 17:01:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-10-2020 17:01:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-10-2020 17:01:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020 17:01:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sample ID: BP18JFInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841312
Page 87 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Sep-10-2020 17:01:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BP18JFInitial Entry
5.b
Date Location User Value Reason
Sep-10-2020 17:02:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sample ID: BPHS4VInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-10-2020 17:02:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BPHS4VInitial Entry
5.c
Date Location User Value Reason
Sep-10-2020 17:02:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sample ID: BPHS4WInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-10-2020 17:02:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BPHS4WInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841313
Page 88 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 17:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 17:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 17:02:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-10-2020 17:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-10-2020 17:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020 17:02:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sample ID: BP18JMInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841314
Page 89 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Sep-10-2020 17:02:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BP18JMInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841315
Page 90 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-10-2020 13:27:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020 13:27:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020 13:27:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020 13:27:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sep/10/2020 12:16Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020 13:27:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-10-2020 13:27:18
(UTC-05:00) EasternACV0PFEINFP6000 Hector
AguilarData Entry:
LEFTInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841316
Page 91 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-10-2020 13:27:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020 13:27:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-10-2020 13:27:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841317
Page 92 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-10-2020 13:27:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841318
Page 93 of 128
***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: 11561124 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 14:08:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Oct/2/2020Initial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841319
Page 94 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Oct-02-2020 14:09:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Oct/2/2020Initial Entry
2.a
Date Location User Value Reason
Oct-02-2020 14:09:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Record Identifier:
:1
Temperature: 98.2
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-02-2020 14:09:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-02-2020 14:09:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-02-2020 14:09:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
FInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841320
Page 95 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.a Temperature Location:
Date Location User Value Reason
Oct-02-2020 14:09:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841321
Page 96 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020 17:35:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020 17:35:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020 17:35:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-02-2020 17:35:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-02-2020 17:35:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YES
Date of Collection:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020 17:35:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sample ID: BR2YYJInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841322
Page 97 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Oct-02-2020 17:35:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BR2YYJInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841323
Page 98 of 128
***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: 11561124 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-02-2020 14:09:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-02-2020 14:09:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-02-2020 14:09:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-02-2020 14:09:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Oct/2/2020 10:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-02-2020 14:09:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-02-2020 14:09:42
(UTC-05:00) EasternACV0PFEINFP6000 Hector
AguilarData Entry:
LEFTInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841324
Page 99 of 128
***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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-02-2020 14:09:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-02-2020 14:09:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-02-2020 14:09:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841325
Page 100 of 128
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 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
Nov-26-2020 07:47:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Closed date amended
Nov-25-2020 15:21:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Nov/2/2020Changed Information
Nov-25-2020 10:20:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarQuery 1: Answered PLEASE ADVICE
WHERE IN THE
PROTOCAL I CAN
FIND THIS
INFORMATION.
THANK YOU.
Nov-25-2020 07:51:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Reissued:Opened CLINQUERY: It is
understood that
notice to site would
have come after
death. However, for
data standardisation
on the trial this field
gets matched to the
date of death for fatal
events. Please review
Nov-24-2020 16:27:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarQuery 1: Answered DATE OF
DISPOSITION
CANNOT BE
02NOV20
BECAUSE THE
SITE WAS
UNAWARE OF THE
SUBJECTS DEATH.
THE DATE
11/19/2020 IS
WHEN THE SITE
DISCOVERED THE
SUBJECT HAD
PASSED.
Nov-24-2020 16:24:12 ACV0PFEINFP6000 Hayley Query 1: Opened CLINQUERY: Per
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841326
Page 101 of 128
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00) Eastern
Time (US & Canada)Wyper AE log, death
occurred on
02Nov20. Please
review, field should
match date of death
Nov-24-2020 15:59:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Nov/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-24-2020 15:59:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-24-2020 16:03:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-24-2020 15:59:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Response to 'Status'
is 'Death' on
Disposition- Folow
up, but 'Death' CRF
is not yet initiated.
Please review and
update as
appropriate.
Nov-24-2020 15:59:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
DEATHInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841327
Page 102 of 128
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 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
Nov-26-2020 07:47:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Closed date amended
Nov-26-2020 04:55:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Date updated to 02Nov2020
Nov-25-2020 15:21:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Nov/2/2020Changed Information
Nov-25-2020 10:21:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarQuery 1: Answered PLEASE ADVISE WHERE
IN THE PROTOCAL I
CAN FIND THIS
INFORMATION. THANK
YOU.
Nov-25-2020 10:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarQuery 2: Answered THE DISPOSITION
FORM IS 19NOV
BECAUSE THAT WAS
WHEN THE SITE
BECAME AWARE FOR
THE DEATH.
Nov-25-2020 07:51:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Reissued:Opened CLINQUERY: It is
understood that notice to
site would have come after
death. However, for data
standardisation on the trial
this field gets matched to
the date of death for fatal
events. Please review
Nov-25-2020 05:22:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON:
AER#2020459412,date of
death was reported as
02Nov2020 in Safety
database but the field 'Date
of
Completion/Discontinuation
/Death' in follow up
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841328
Page 103 of 128
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
disposition form was
answered 19Nov2020.
Please confirm and update
accordingly.
Nov-24-2020 16:27:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarQuery 1: Answered DATE OF DISPOSITION
CANNOT BE 02NOV20
BECAUSE THE SITE
WAS UNAWARE OF THE
SUBJECTS DEATH. THE
DATE 11/19/2020 IS
WHEN THE SITE
DISCOVERED THE
SUBJECT HAD PASSED.
Nov-24-2020 16:24:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Opened CLINQUERY: Per AE log,
death occurred on 02Nov20.
Please review, field should
match date of death
Nov-24-2020 16:00:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Nov/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-24-2020 16:00:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Nov-24-2020 16:03:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-24-2020 16:00:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Response to 'Status'
is 'Death' on
Disposition- Folow
up, but 'Death' CRF
is not yet initiated.
Please review and
update as
appropriate.
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841329
Page 104 of 128
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-24-2020 16:00:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
DEATHInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841330
Page 105 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Nov-23-2020 15:49:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hector
AguilarForm Created
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841331
Page 106 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Jan-05-2021 16:46:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hector
AguilarForm Created
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841332
Page 107 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Nov-23-2020 15:49:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-23-2020 15:49:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Feb-19-2021
12:07:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query
3: Clo
sedResponse satisfies
query
Feb-17-2021
14:49:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Hector Aguilar Query
3: An
swere
dEVENT WAS NOT
WITNESSED.
Feb-17-2021
11:11:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query
3: Op
enedMedical Monitor_
Per report, "the
subject experienced
respiratory arrest ".
Pls clarify if this
event was
witnessed. Thanks
Jan-05-2021
22:28:36
(UTC-05:00)
Eastern TimeACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
2: Clo
sedDiscrepancy has
been closed.
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841333
Page 108 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(US &
Canada)
Jan-05-2021
16:44:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query
2: An
swere
dNew Information
Jan-05-2021
16:44:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Hector Aguilar Data
Entry
:
RESP
IRAT
ORY
ARR
ESTNew Information
Jan-05-2021
08:11:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dCorrect. The
current AE entry
contains multiple
terms. Please
consider splitting
the term into
RESPIRATORY
ARREST and
MULTIPLE
DRUGS
OVERDOSE and
report as 2 separate
entries. Thank you.
Dec-28-2020
13:20:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Hector Aguilar Query
2: An
swere
dSO INSEATD OF 1
AE, 2 AE(S) ARE
NEEDED AS
(1)RESPIRATORY
ARREST AND (2)
MULTIPLE DRUG
OVERDOSE?
Dec-24-2020
06:05:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies
query
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841334
Page 109 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Dec-24-2020
04:26:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
2: Op
enedMultiple concepts
in the term
RESPIRATORY
ARREST DUE TO
MULTIPLE
DRUGS
OVERDOSE. Split
the term into
RESPIRATORY
ARREST and
MULTIPLE
DRUGS
OVERDOSE and
report as 2 separate
entries. Thank you.
Dec-23-2020
13:29:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query
1: An
swere
dNew Information
Dec-23-2020
13:29:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Hector Aguilar Data
Entry
:
RESP
IRAT
ORY
ARR
EST
DUE
TO M
ULTI
PLE
DRU
GS O
VER
DOSENew Information
Nov-30-2020
05:45:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM: Please provide
disease name or
event which leads
to death when data
is available. Thank
you.
Nov-26-2020 ACV0PFEINFP6000 QueryDM: Please provide
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841335
Page 110 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
08:56:50
(UTC-05:00)
Eastern Time
(US &
Canada)1: Rei
ssued:
Candi
datedisease name or
event which leads
to death when data
is available. Thank
you.
Nov-25-2020
10:16:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Hector Aguilar Query
1: An
swere
dAS OF NOW,
INFORMATION IS
NOT KNOWN
Nov-25-2020
02:09:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM: Please provide
disease name or
event which leads
to death. Thank
you.
Nov-24-2020
09:53:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Hector Aguilar Query
1: An
swere
dCAUSE OF
DEATH IS YET
TO BE
DETERMINED
Nov-24-2020
04:10:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6230302;This
'Adverse Event'
contains the term
DEATH. If known,
please provide the
cause of death as
the AE term with an
outcome of FATAL
or clarify.
Nov-23-2020
15:49:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Hector Aguilar Data
Entry
:
SUD
DEN
CAR
DIAC
DEAT
HInitial Entry
4. Start Date Time:
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841336
Page 111 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-23-2020 15:49:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Nov/2/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-23-2020 15:49:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NO
End Date Time:
Nov/2/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-24-2020 16:19:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Closed Response satisfies
query
Nov-24-2020 16:03:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Nov-24-2020 16:03:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
4Initial Entry
Nov-24-2020 16:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry: Initial Entry
Nov-24-2020 15:52:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Reissued:Opened CLINQUERY: The
fatal events are
reported at the highest
toxicity grade of the
trial, is G4.
Nov-24-2020 09:55:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarQuery 1: Answered PLEASE EXPLAIN
WHY THIS EVENT
THAT LED TO
DEATH WOULD BE
CONSIDERED
LIFE-THREATNING?
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841337
Page 112 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-24-2020 07:06:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Opened CLINQUERY: Since
fatal event reported,
please update toxicity
field to capture G4
event per 10.3.3
Nov-23-2020 15:50:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Not ApplicableInitial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-25-2020 01:40:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-23-2020 15:49:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE SUDDEN
CARDIAC
DEATH: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Nov-23-2020 15:49:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in d
eath?
YES
Did this serious event require or
prolong hospitalization?Initial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841338
Page 113 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
NO
Did this serious event result in p
ersistent or significant disability
/incapacity?
NO
Is this serious event life threaten
ing?
NO
Other medically important serio
us event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-23-2020 15:49:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-08-2021 08:15:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-07-2021 16:13:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarQuery 1: Answered SUBJECT DOES
NOT HAVE HX OF
SUBSTANCE
ABUSE
Jan-07-2021 15:33:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened clinical:Thank you. If
the subject has a prior
hx of substance abuse
disorder the MedHx
CRF should be
updated accordingly.
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841339
Page 114 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Jan-07-2021 14:45:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarQuery 1: Answered FENTANYL,
DESPROPIONYL
FENTANYL
(4-ANPP),
ENTHANOL AND
ALPRAZOLAM
INTOXICATION.
Jan-07-2021 10:57:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened clinical: pls advise
what drugs subject
took. Thanks
Dec-23-2020 13:29:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
DRUG OVERDOSENew Information
Nov-23-2020 15:49:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
UNKNOWN CAUSEInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-23-2020 15:49:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-23-2020 15:49:49
(UTC-05:00) EasternACV0PFEINFP6000 Hector
AguilarData Entry:
NOInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841340
Page 115 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-23-2020 15:49:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-25-2020 03:56:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-24-2020 16:03:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto Query
Nov-24-2020 00:57:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Response doesn't
satisfy query. If
outcome of this AE
is FATAL, kindly
complete the
DEATH DTL form
at visit named DISP
as well as he
DISPOSITION-
TREATMENT form
at visit named EOT
accordingly. If not
FATAL, please
update and correct.
Nov-23-2020 15:55:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarQuery 1: Answered Original value is
correct
Nov-23-2020 15:49:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "What
was the outcome of
this adverse event?"
is 'Fatal' but Date of
Collection /
Notification of Death
on the Death Details
form is not
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0841341
Page 116 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
completed. Please
review and update as
appropriate.
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841342
Page 117 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-23-2020 15:49:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
FATALInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-24-2020 16:25:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Closed Response satisfies
query
Nov-24-2020 16:04:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarQuery 1: Answered EOT AND FUP
HAVE BEEN
COMPLETED
Nov-24-2020 06:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Opened CLINQUERY: Fatal
event: EOT tab and
FUP tab to be
completed to
indicate end of
treatment phase and
end of study. Please
update
Nov-23-2020 15:49:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YESInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-25-2020 01:40:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020459412Initial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841343
Page 118 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Jan-05-2021 16:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-05-2021 16:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-19-2021 12:26:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Feb-17-2021 14:53:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarQuery 1: Answered SUBJECT DOES
NOT HAVE A
HISTORY OF
ILLEGAL DRUG
USE.
Feb-17-2021 07:02:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Medical Monitor_
Pls clarify if the
subject had a
history of drug use.
Thanks
Jan-05-2021 16:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
MULTIPLE DRUG OVERDOSEInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-05-2021 16:46:50
(UTC-05:00) EasternACV0PFEINFP6000 Hector
AguilarData Entry:
Nov/2/2020 UNK:UNKInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841344
Page 119 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-05-2021 16:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NO
End Date Time:
Nov/2/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-05-2021 16:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-05-2021 22:21:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be
addressed internally
Jan-05-2021 16:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE MULTIPLE
DRUG
OVERDOSE:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Jan-05-2021 16:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?Initial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841345
Page 120 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
NO
Did this serious event result in
death?
YES
Did this serious event require or
prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabilit
y/incapacity?
NO
Is this serious event life threate
ning?
YES
Other medically important serio
us event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-05-2021 16:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-18-2021 09:37:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-15-2021 13:19:57
(UTC-05:00) EasternACV0PFEINFP6000 Hector
AguilarQuery 1: Answered THE SUBJECT
HAD THE
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841346
Page 121 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada) AE(MULTIPLE
DRUG
OVERDOSE). IT
WAS NOT
RELATED. THE
REASON (OTHER)
AS TO WHY HE
HAD MULTIPLE
DRUG OVERDOSE
WAS BECAUSE
THE SUBJECTS
TOOK DRUGS.
Jan-14-2021 17:14:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Multiple
Drug Overdose is
reported as being
related to Other:
Drug Overdose.
However, the
Causality can't match
the AE term as this
does not explain the
most likely cause of
the AE. Please
clarify the cause &
update accordingly
Jan-05-2021 16:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
DRUG OVERDOSEInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-05-2021 16:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841347
Page 122 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Jan-05-2021 16:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-05-2021 16:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-05-2021 16:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
FATALInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-05-2021 23:59:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-05-2021 16:50:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarQuery 1: Answered BOTH AE(S) WERE
PREVIOUSLY 1,
BUT THEY
NEEDED TO BE
SPLIT INTO 2.
BOTH EVENTS
LED THE SUBJECT
TO BE
DISCONTINUED
Jan-05-2021 16:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened More than 1 AE for
this patient has "Did
the adverse event
cause the subject to
be discontinued from
the study?" marked
as 'Yes'.
Jan-05-2021 16:46:50 ACV0PFEINFP6000 Hector Data Entry: Initial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841348
Page 123 of 128
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00) Eastern
Time (US & Canada)Aguilar YES
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-06-2021 06:41:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020459412Initial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841349
Page 124 of 128
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - 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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Feb-02-2021 11:18:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-01-2021 16:49:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector Aguilar Query 1: Answered UPDATED
Jan-29-2021 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Please
update the CRF
with the Cause of
Death Status and
Cause of Death for
data completion.
Jan-29-2021 12:44:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Candidate ClinQuery: Please
update the CRF
with the Cause of
Death Status and
Cause of Death for
data completion.
Nov-25-2020 15:21:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector Aguilar Data Entry:
Nov/2/2020Changed
Information
Nov-24-2020 16:03:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector Aguilar Data Entry:
Nov/19/2020Initial Entry
2.a
Date Location User Value Reason
Feb-01-2021 16:48:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Cause of Dea
th Status:PRIMARY CAUS
E OF DEATH
Cause of Dea
th:RESPIRATORY
ARRESTInitial Entry
2.a Cause of Death Status:
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841350
Page 125 of 128
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - 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: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Feb-01-2021 16:48:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
PRIMARY CAUSE OF DEATHInitial Entry
2.a Cause of Death:
Date Location User Value Reason
Mar-04-2021 09:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-03-2021 13:01:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarQuery 1: Answered RESPIRATORY
ARREST WAS THE
CAUSE OF DEATH.
Mar-02-2021 18:26:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please clarify if
MULTIPLE DRUG
OVERDOSE should
also be reported as a
cause of death. Note:
MULTIPLE DRUG
OVERDOSE is also
reported with a fatal
outcome.
Feb-01-2021 16:48:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
RESPIRATORY ARRESTInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841351
Page 126 of 128
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-24-2020 16:00:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Nov-24-2020 15:59:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Sep-10-2020 13:26:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-10-2020 13:25:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-25-2020 15:21:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/2/2020Changed Information
Nov-25-2020 15:21:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/2/2020Changed Information
Nov-25-2020 01:41:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Nov-24-2020 16:00:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/19/2020Initial Entry
Nov-24-2020 15:59:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/19/2020Initial Entry
Nov-23-2020 15:55:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hector
AguilarQuery 1: Answered AE WAS SUBMITTED
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841352
Page 127 of 128
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-23-2020 05:03:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020459412
Sudden cardiac death
(clinical judgement)(onset
date:02Nov2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Sep-10-2020 13:26:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
Sep-10-2020 13:25:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0841353
Page 128 of 128
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561124 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-09-2020 14:44:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae30ba\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0841354