Document text
Page 1 of 182
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006550
Page 2 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/25/2020
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006551
Page 3 of 182
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Demography
1.Subject ID [44442041]
2.Birth Date: /1965
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006552
Page 4 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006553
Page 5 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006554
Page 6 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006555
Page 7 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006556
Page 8 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006557
Page 9 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
2.Weight: [47.6]
3.Unit: kg
4.Height: [163.0]
5.Unit: cm
6.Body Mass Index: [17.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006558
Page 10 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/25/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006559
Page 11 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/25/2020
2.Randomization Number: [100478]
3.Randomization Group: [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006560
Page 12 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BKPG68]
5.bSample ID [BRVS3L]
5.cSample ID [BRVS3V]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006561
Page 13 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BPWSCH]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006562
Page 14 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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/25/2020 18:39
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
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006563
Page 15 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006564
Page 16 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006565
Page 17 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Oct/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006566
Page 18 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/16/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006567
Page 19 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
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 [BKVDPM]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006568
Page 20 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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/16/2020 16:35
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
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006569
Page 21 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020
2.Erroneous Visit
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006570
Page 22 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/13/2020
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 [BPTB82]
5.bSample ID [BRVSFB]
5.cSample ID [BRVSC2]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006571
Page 23 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006572
Page 24 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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: [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006573
Page 25 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006574
Page 26 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006575
Page 27 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006576
Page 28 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006577
Page 29 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006578
Page 30 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006579
Page 31 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006580
Page 32 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006581
Page 33 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006582
Page 34 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Unplanned Assessments
1.Assessments
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006583
Page 35 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Right displaced proximal hu
meral fracture Dec/5/2020
12:00 NO
End Date Time:
Jan/14/2021 18:00
Repeating
Pages
2.ADVERSE E
VENT 2 Fall down stairs Dec/5/2020
12:00 NO
End Date Time:
Dec/5/2020 12:03
Repeating
Pages
3.ADVERSE E
VENT 3 Reactive depression Jan/25/2021
12:00 YES Repeating
Pages
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006584
Page 36 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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)[Right displaced proximal humeral fracture]
4.Start Date Time: Dec/5/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/14/2021 18:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006585
Page 37 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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:
[Fall down stairs]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020510058]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006586
Page 38 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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)[Fall down stairs]
4.Start Date Time: Dec/5/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/5/2020 12:03
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006587
Page 39 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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:
[Accidental slip]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006588
Page 40 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Reactive depression]
4.Start Date Time: Jan/25/2021 12:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Related to his history of humerus fracture.]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006589
Page 41 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006590
Page 42 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006591
Page 43 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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[ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006592
Page 44 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006593
Page 45 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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: //
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006594
Page 46 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006595
Page 47 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006596
Page 48 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006597
Page 49 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006598
Page 50 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006599
Page 51 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006600
Page 52 of 182
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006601
Page 53 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006602
Page 54 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006603
Page 55 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006604
Page 56 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006605
Page 57 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006606
Page 58 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006607
Page 59 of 182
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/6/2021
2.Erroneous Visit
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006608
Page 60 of 182
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/6/2021
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006609
Page 61 of 182
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/6/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS43YJ]
5.bSample ID [BS43ZW]
5.cSample ID [BPTHBG]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006610
Page 62 of 182
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/6/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWDD3]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006611
Page 63 of 182
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006612
Page 64 of 182
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/24/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK2
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006613
Page 65 of 182
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/24/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMCRF]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006614
Page 66 of 182
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/06/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/6/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK4
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006615
Page 67 of 182
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/06/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/6/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR227L]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006616
Page 68 of 182
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/6/2021
2.Erroneous Visit
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006617
Page 69 of 182
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006618
Page 70 of 182
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/6/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006619
Page 71 of 182
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006620
Page 72 of 182
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006621
Page 73 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006622
Page 74 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/10/2021
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006623
Page 75 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006624
Page 76 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Mar/10/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006625
Page 77 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/10/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006626
Page 78 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/10/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRYXG4]
5.bSample ID [BR1P25]
5.cSample ID [BRYF35]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006627
Page 79 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/10/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR1PMW]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006628
Page 80 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/10/2021 12:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006629
Page 81 of 182
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006630
Page 82 of 182
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006631
Page 83 of 182
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006632
Page 84 of 182
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006633
Page 85 of 182
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006634
Page 86 of 182
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006635
Page 87 of 182
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006636
Page 88 of 182
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006637
Page 89 of 182
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006638
Page 90 of 182
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006639
Page 91 of 182
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006640
Page 92 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/13/2020
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006641
Page 93 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006642
Page 94 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006643
Page 95 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-27-2020 10:58:08 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006644
Page 96 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-27-2020 10:59:06 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006645
Page 97 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormMar-10-2021 14:13:09 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006646
Page 98 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-08-2021 19:11:08 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-08-2021 15:53:23 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , 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.
Agustin Morato
Cabral N/A Feb-26-2021 08:39:34 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Tatiana Estrada Approved Feb-16-2021 16:57:42 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006647
Page 99 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, TatianaEstrada, 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.
Agustin Morato
Cabral N/A Feb-08-2021 17:53:32 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-08-2021 17:47:21 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-07-2021 10:59:39 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-22-2021 12:17:52 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006648
Page 100 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-23-2020 13:31:59 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-14-2020 12:22:11 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-13-2020 16:34:06 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Maria Beretta Approved Nov-10-2020 11:56:02 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006649
Page 101 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, MariaBeretta, 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.
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006650
Page 102 of 182
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-27-2020 10:57:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-27-2020 10:57:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006651
Page 103 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-27-2020 10:57:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/25/2020Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006652
Page 104 of 182
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-25-2020 18:08:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
44442041Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-25-2020 18:08:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1965Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-27-2020 10:57:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-27-2020 10:57:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-27-2020 10:57:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006653
Page 105 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-27-2020 10:57:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006654
Page 106 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-27-2020 10:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-27-2020 10:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-27-2020 10:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006655
Page 107 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-27-2020 10:59:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006656
Page 108 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Sep-27-2020 10:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-27-2020 10:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
47.6Initial Entry
3. Unit:
Date Location User Value Reason
Sep-27-2020 10:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-27-2020 10:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
163.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-27-2020 10:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006657
Page 109 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
6. Body Mass Index:
Date Location User Value Reason
Sep-27-2020 10:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17.9Initial Entry
7.a
Date Location User Value Reason
Sep-27-2020 10:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 37.0
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-27-2020 10:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-27-2020 10:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4), (b) (6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006658
Page 110 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-27-2020 10:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-27-2020 10:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006659
Page 111 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-27-2020 11:00:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-27-2020 11:00:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-27-2020 11:00:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-27-2020 11:00:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-27-2020 11:00:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006660
Page 112 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Sep-27-2020 11:00:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-27-2020 11:00:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-27-2020 11:00:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Sep-27-2020 11:00:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006661
Page 113 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-27-2020 11:00:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-27-2020 11:00:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
100478Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006662
Page 114 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-27-2020 11:00:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-27-2020 11:00:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-27-2020 11:10:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-27-2020 11:00:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-27-2020 11:00:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-27-2020 11:10:35 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4), (b) (6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006663
Page 115 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos AiresSample ID: BKPG68
5.a Sample ID
Date Location User Value Reason
Sep-27-2020 11:10:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BKPG68Initial Entry
5.b
Date Location User Value Reason
Sep-27-2020 11:40:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRVS3LInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-27-2020 11:40:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRVS3LInitial Entry
5.c
Date Location User Value Reason
Sep-27-2020 12:03:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Sample ID: BRVS3VInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-27-2020 12:03:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
BRVS3VInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1006664
Page 116 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-27-2020 11:00:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-27-2020 11:00:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-27-2020 14:59:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-27-2020 11:00:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-27-2020 11:00:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-27-2020 14:59:55 ACV0PFEINFP6000 Alan Colombo Data Entry: Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006665
Page 117 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos AiresSample ID: BPWSCH
5.a Sample ID
Date Location User Value Reason
Sep-27-2020 14:59:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BPWSCHInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006666
Page 118 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-27-2020 11:03:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-27-2020 11:01:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-27-2020 11:01:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-27-2020 11:01:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020 18:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-27-2020 11:01:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006667
Page 119 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Sep-27-2020 11:01:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-27-2020 11:01:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-27-2020 11:01:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-27-2020 11:01:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006668
Page 120 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-27-2020 11:01:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006669
Page 121 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020 10:27:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/16/2020Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006670
Page 122 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Oct-19-2020 10:33:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/16/2020Initial Entry
2.a
Date Location User Value Reason
Oct-19-2020 10:32:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 36.8
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-19-2020 10:32:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-19-2020 10:32:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-19-2020 10:32:30 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006671
Page 123 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos AiresC
2.a Temperature Location:
Date Location User Value Reason
Oct-19-2020 10:32:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006672
Page 124 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-19-2020 10:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-19-2020 10:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-19-2020 10:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-19-2020 10:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-19-2020 10:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006673
Page 125 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Oct-19-2020 10:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-19-2020 10:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-19-2020 10:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Oct-19-2020 10:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006674
Page 126 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 18:51:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 18:51:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 18:51:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 18:51:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-16-2020 18:51:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006675
Page 127 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-16-2020 18:51:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BKVDPMInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 18:51:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BKVDPMInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006676
Page 128 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-19-2020 10:33:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-19-2020 10:33:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-19-2020 10:33:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-19-2020 10:33:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/16/2020 16:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-19-2020 10:33:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006677
Page 129 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-19-2020 10:33:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-19-2020 10:33:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-19-2020 10:33:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-19-2020 10:33:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006678
Page 130 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-13-2020 16:34:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006679
Page 131 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020 16:34:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020 16:34:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020 18:16:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-13-2020 16:34:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-13-2020 16:34:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/13/2020Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020 18:16:42 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1006680
Page 132 of 182
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos AiresSample ID: BPTB82
5.a Sample ID
Date Location User Value Reason
Nov-13-2020 18:16:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPTB82Initial Entry
5.b
Date Location User Value Reason
Nov-13-2020 18:22:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BRVSFBInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-13-2020 18:22:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BRVSFBInitial Entry
5.c
Date Location User Value Reason
Nov-14-2020 12:20:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Sample ID: BRVSC2Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-14-2020 12:20:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
BRVSC2Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1006681
Page 133 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006682
Page 134 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Jan-06-2021 12:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006683
Page 135 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Feb-07-2021 10:59:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006684
Page 136 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-03-2021 14:28:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-30-2021 11:24:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Please clarify the
request, on JAN 25,
FU was sent and it
evolved into HC
clarifying the
aforementioned.
Jan-28-2021 19:51:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened Clinical Thank you;
please submit a
SAE update to
clarify the fracture
of the 'prox 3rd
portion of the Rt
humerus'
Jan-26-2021 11:40:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered It's clarify that
Right shoulder
X-ray and CT scan
reported proximal
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006685
Page 137 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
third portion
fracture on her right
humerus,
compatible with a
type N3 fracture.
Jan-25-2021 10:34:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Clinical In SAE
report, Xray & CT
finding describing
the fracture is
reported as
"proximal third
continuity solution
of her right
humerus". Please
clarify 'continuity'
(a 3rd portion of the
bone?) and
'solution'
Jan-23-2021 00:18:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Candidate Clinical In SAE
report, Xray & CT
finding describing
the fracture is
reported as
"proximal third
continuity solution
of her right
humerus". Please
clarify 'continuity'
(a 3rd portion of the
bone?) and
'solution'
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Right displaced proximal hum
eral fractureInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/5/2020 12:00Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006686
Page 138 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-16-2021 19:31:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/14/2021 18:00New Information
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-21-2021 01:41:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Jan-15-2021 11:38:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered It is recorded in the
initial SAE under
studies carried out
during
hospitalization.
Thank you.
Jan-13-2021 19:22:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Reissued:Opened Clinical Thank you;
please submit that
information (tested
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006687
Page 139 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
during
hospitalization) to
the SAE as a safety
update.
Jan-09-2021 10:35:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered The Covid test was
carried out within
the hospitalization
period.
Jan-08-2021 12:16:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened CLINICAL SAE
report states that
date of (negative)
COVID test is
unknown. However,
please clarify if it
was performed as
an outpatient, or
during the Dec
20-21
hospitalization.
Jan-06-2021 00:26:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Deleted Query can be
addressed internally
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Right
displaced proximal
humeral fracture:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event resultInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006688
Page 140 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
in death?
NO
Did this serious event requir
e or prolong hospitalization?
YES
Did this serious event result
in persistent or significant di
sability/incapacity?
NO
Is this serious event life thre
atening?
NO
Other medically important s
erious 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
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-08-2021 12:05:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Jan-06-2021 12:27:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered The AE "Fall
down Stairs" was
added with all
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006689
Page 141 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
information
available. Thank
you.
Jan-04-2021 19:25:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened Clinical Per CRF
completion
guidelines Sect
8.50.2.2; a fall
needs to be
reported recorded
as an AE as well,
even if an injury
did not result.
Jan-03-2021 13:06:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-24-2020 11:35:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiQuery 1: Answered The subject just
tripped. Thank
you.
Dec-24-2020 09:13:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Clinquery:
Presumably
fracture was fixed.
Was there
anything which
precipitated the
fall down the
stairs, eg
dizziness; or
participant just
tripped?
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
Fall down stairsInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006690
Page 142 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-16-2021 19:32:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-16-2021 19:32:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Jan-16-2021 19:31:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Right
displaced proximal
humeral fracture:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006691
Page 143 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVIN
GInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-23-2020 13:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-06-2021 10:52:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2020510058Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006692
Page 144 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Jan-06-2021 12:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-06-2021 12:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-06-2021 12:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Fall down stairsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-06-2021 12:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/5/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-06-2021 12:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/5/2020 12:03Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006693
Page 145 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
6. Toxicity Grade:
Date Location User Value Reason
Jan-06-2021 12:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial 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-06-2021 12:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-06-2021 12:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-06-2021 12:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
Accidental slipInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006694
Page 146 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-06-2021 12:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-06-2021 12:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-06-2021 12:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-06-2021 12:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-06-2021 12:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006695
Page 147 of 182
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Feb-07-2021 10:59:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-07-2021 10:59:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-07-2021 10:59:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Reactive depressionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-07-2021 10:59:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/25/2021 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-07-2021 10:59:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006696
Page 148 of 182
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
6. Toxicity Grade:
Date Location User Value Reason
Feb-07-2021 10:59:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial 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
Feb-07-2021 10:59:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-07-2021 10:59:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-11-2021
01:43:14
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query 1
: ClosedResponse
satisfies query
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006697
Page 149 of 182
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-10-2021
12:08:24
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query 1
: Answe
redThe humerus
fracture has
already been
charged as a
separate
adverse event.
The Reactive
depression is
related to the
adverse event
mentioned
above. Thank
you
Feb-10-2021
02:55:24
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1
: Opene
dPlease review
"If not related
to study
treatment
other" field, the
following text
was indicated
in the comment
field [humerus
fracture]. Any
symptoms, AEs
or other key
data should be
collected on the
appropriate
page. Please
review and
update as
necessary.
Feb-07-2021
10:59:39
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy treInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006698
Page 150 of 182
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
atment
(s), thi
s event
is due
to:
OTH
ER
If
Oth
er,
spe
cify
:
R
el
at
ed
to
hi
s
hi
st
or
y
of
h
u
m
er
us
fr
ac
tu
re
.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-07-2021 10:59:39 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1006699
Page 151 of 182
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos AiresNOT APPLICABLE
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-07-2021 10:59:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-07-2021 10:59:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-07-2021 10:59:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-10-2021 09:03:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-09-2021 16:19:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-09-2021 16:19:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOTranscription Error
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006700
Page 152 of 182
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-09-2021 13:43:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: "Did the
event cause the
Subject to be
Discontinued from
the Study" is
marked as YES
however AE
outcome is not
FATAL. Please
verify and update
the data as
appropriate. If
confirmed, please
consider to update
the FUP form as
well. Thank you.
Feb-07-2021 10:59:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006701
Page 153 of 182
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-13-2020 16:34:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-13-2020 16:34:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-13-2020 16:34:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006702
Page 154 of 182
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-07-2021 21:15:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/6/2021Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006703
Page 155 of 182
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-07-2021 21:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/6/2021Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006704
Page 156 of 182
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-07-2021 21:15:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-07-2021 21:15:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-08-2021 13:05:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-08-2021 06:48:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-07-2021 21:15:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-07-2021 21:15:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006705
Page 157 of 182
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb/6/2021
5.a
Date Location User Value Reason
Feb-08-2021 13:05:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Sample ID: BS43YJInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-08-2021 13:05:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
BS43YJInitial Entry
5.b
Date Location User Value Reason
Feb-08-2021 17:53:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Sample ID: BS43ZWInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-08-2021 17:53:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
BS43ZWInitial Entry
5.c
Date Location User Value Reason
Feb-09-2021 09:29:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPTHBGInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006706
Page 158 of 182
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.c Sample ID
Date Location User Value Reason
Feb-09-2021 09:29:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPTHBGInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006707
Page 159 of 182
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-07-2021 21:16:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-07-2021 21:16:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-08-2021 12:23:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-08-2021 06:48:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-07-2021 21:16:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-07-2021 21:16:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006708
Page 160 of 182
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb/6/2021
5.a
Date Location User Value Reason
Feb-08-2021 12:23:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPWDD3Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-08-2021 12:23:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPWDD3Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006709
Page 161 of 182
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/24/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021 08:39:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Feb/24/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-26-2021 08:39:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
SSWAB_WEEK2Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006710
Page 162 of 182
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/24/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021 08:40:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021 08:40:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021 08:40:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-26-2021 08:40:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-26-2021 08:40:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
YES
Date of Collection:
Feb/24/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006711
Page 163 of 182
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/24/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-26-2021 08:40:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Sample ID: BRMCRFInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-26-2021 08:40:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
BRMCRFInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006712
Page 164 of 182
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/06/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021 19:11:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/6/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Mar-08-2021 19:11:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SSWAB_WEEK4Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006713
Page 165 of 182
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/06/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021 19:11:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021 19:11:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-08-2021 19:11:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-08-2021 19:11:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-08-2021 19:11:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/6/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006714
Page 166 of 182
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/06/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Mar-08-2021 19:11:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BR227LInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-08-2021 19:11:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR227LInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006715
Page 167 of 182
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021 14:16:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/6/2021Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006716
Page 168 of 182
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-08-2021 14:16:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible per other protocol all
owance(s) and confirmed to h
ave received only placebo at
Vaccination 1/2Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006717
Page 169 of 182
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-08-2021 14:16:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/6/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-08-2021 14:16:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006718
Page 170 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-10-2021 14:12:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/10/2021Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006719
Page 171 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Mar-10-2021 14:12:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Mar/10/2021Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006720
Page 172 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-10-2021 14:13:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/10/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-10-2021 14:13:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Mar-10-2021 14:13:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006721
Page 173 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-10-2021 14:13:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Mar-10-2021 14:13:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Mar-10-2021 14:13:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/10/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Mar-10-2021 14:13:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Mar-10-2021 14:13:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006722
Page 174 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Mar-10-2021 14:13:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Mar-10-2021 14:13:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Mar-10-2021 14:13:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Mar-10-2021 14:13:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006723
Page 175 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-10-2021 14:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-10-2021 14:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-10-2021 15:22:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-10-2021 14:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-10-2021 14:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/10/2021Initial Entry
5.a
Date Location User Value Reason
Mar-10-2021 15:22:24 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1006724
Page 176 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos AiresSample ID: BRYXG4
5.a Sample ID
Date Location User Value Reason
Mar-10-2021 15:22:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRYXG4Initial Entry
5.b
Date Location User Value Reason
Mar-10-2021 15:44:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BR1P25Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-10-2021 15:44:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR1P25Initial Entry
5.c
Date Location User Value Reason
Mar-10-2021 17:54:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRYF35Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-10-2021 17:54:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRYF35Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006725
Page 177 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-10-2021 14:14:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-10-2021 14:14:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-10-2021 17:08:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-10-2021 14:14:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-10-2021 14:14:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/10/2021Initial Entry
5.a
Date Location User Value Reason
Mar-10-2021 17:08:19 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1006726
Page 178 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos AiresSample ID: BR1PMW
5.a Sample ID
Date Location User Value Reason
Mar-10-2021 17:08:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR1PMWInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006727
Page 179 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-10-2021 14:14:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-10-2021 14:14:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-10-2021 14:14:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-10-2021 14:14:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/10/2021 12:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-10-2021 14:14:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006728
Page 180 of 182
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Mar-10-2021 14:14:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Mar-10-2021 14:14:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-10-2021 14:14:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-10-2021 14:14:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-10-2021 14:14:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Mar-10-2021 14:14:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006729
Page 181 of 182
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-13-2020 16:34:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-27-2020 11:00:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-27-2020 10:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-13-2020 16:34:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/13/2020Initial Entry
Sep-27-2020 11:00:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
Sep-27-2020 10:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006730
Page 182 of 182
***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, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44442041 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020 11:55:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria Beretta Data Entry:
Click Here to EnableInitial Entry
090177e196ae2e6d\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006731