Document text
Page 1 of 153
***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: 44442278 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
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006732
Page 2 of 153
***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: 44442278 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/27/2020
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006733
Page 3 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Demography
1.Subject ID [44442278]
2.Birth Date: /1977
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006734
Page 4 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/27/2020
2.Erroneous Visit
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006735
Page 5 of 153
***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: 44442278 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
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006736
Page 6 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006737
Page 7 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Arterial hypertension]
Start Date: Sep/1/2013
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[obesity]
Start Date: Jan/10/2018
Ongoing: YES
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006738
Page 8 of 153
***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: 44442278 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
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006739
Page 9 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Sep/27/2020
2.Weight: [132.0]
3.Unit: kg
4.Height: [179.0]
5.Unit: cm
6.Body Mass Index: [41.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006740
Page 10 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/27/2020
2.Randomization Number: [101061]
3.Randomization Group: [ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006741
Page 11 of 153
***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: 44442278 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/27/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRVFLC]
5.bSample ID [BPXJMK]
5.cSample ID [BRVFK5]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006742
Page 12 of 153
***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: 44442278 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/27/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWSMM]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006743
Page 13 of 153
***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: 44442278 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/27/2020 17:08
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006744
Page 14 of 153
***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: 44442278 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
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006745
Page 15 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006746
Page 16 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Oct/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006747
Page 17 of 153
***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: 44442278 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/15/2020
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 [BKNZJJ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006748
Page 18 of 153
***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: 44442278 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/15/2020 15:27
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006749
Page 19 of 153
***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: 44442278 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
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006750
Page 20 of 153
***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: 44442278 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 [BRVS8B]
5.bSample ID [BRVS8N]
5.cSample ID [BPTB5N]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006751
Page 21 of 153
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006752
Page 22 of 153
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 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 [ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006753
Page 23 of 153
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006754
Page 24 of 153
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 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 [ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006755
Page 25 of 153
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006756
Page 26 of 153
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 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 [ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006757
Page 27 of 153
***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: 44442278 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:
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006758
Page 28 of 153
***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: 44442278 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: [ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006759
Page 29 of 153
***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: 44442278 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 [ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006760
Page 30 of 153
***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: 44442278 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 [ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006761
Page 31 of 153
***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: 44442278 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?
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006762
Page 32 of 153
***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: 44442278 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:
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006763
Page 33 of 153
***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: 44442278 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:
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006764
Page 34 of 153
***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: 44442278 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 [ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006765
Page 35 of 153
***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: 44442278 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:
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006766
Page 36 of 153
***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: 44442278 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 [ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006767
Page 37 of 153
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006768
Page 38 of 153
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Unplanned Assessments
1.Assessments
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006769
Page 39 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Fever Oct/16/202
0 11:07 NO
End Date Time:
Oct/17/2020 20:06
Repeating
Pages
2.ADVERSE
EVENT 2 Hypertensive
urgency Mar/4/2021
20:00 NO
End Date Time:
Mar/4/2021 20:30
Repeating
Pages
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006770
Page 40 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 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)[Fever]
4.Start Date Time: Oct/16/2020 11:07
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/17/2020 20:06
6.Toxicity Grade: 1
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006771
Page 41 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006772
Page 42 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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[ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006773
Page 43 of 153
***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: 44442278 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)[Hypertensive urgency]
4.Start Date Time: Mar/4/2021 20:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/4/2021 20:30
6.Toxicity Grade: 3
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006774
Page 44 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
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:
[Worsening of high blood pressure]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006775
Page 45 of 153
***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: 44442278 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?: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[ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006776
Page 46 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006777
Page 47 of 153
***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: 44442278 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[ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006778
Page 48 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006779
Page 49 of 153
***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: 44442278 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: //
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006780
Page 50 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006781
Page 51 of 153
***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: 44442278 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?
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006782
Page 52 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006783
Page 53 of 153
***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: 44442278 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?
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006784
Page 54 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006785
Page 55 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006786
Page 56 of 153
***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: 44442278 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: [ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006787
Page 57 of 153
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006788
Page 58 of 153
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 44442278 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:
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006789
Page 59 of 153
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 44442278 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?
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006790
Page 60 of 153
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006791
Page 61 of 153
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006792
Page 62 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006793
Page 63 of 153
***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: 44442278 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/4/2021
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006794
Page 64 of 153
***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: 44442278 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/4/2021
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 [BNTTHH]
5.bSample ID [BPWD3W]
5.cSample ID [BNTTH7]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006795
Page 65 of 153
***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: 44442278 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/4/2021
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 [BHXGND]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006796
Page 66 of 153
***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: 44442278 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: [ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006797
Page 67 of 153
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/17/2021Form: 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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006798
Page 68 of 153
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/17/2021Form: 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: 44442278 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/17/2021
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 [BR1ML3]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006799
Page 69 of 153
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/01/2021Form: 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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK4
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006800
Page 70 of 153
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/01/2021Form: 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: 44442278 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/1/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR20NF]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006801
Page 71 of 153
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006802
Page 72 of 153
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006803
Page 73 of 153
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for
Unblinding:
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006804
Page 74 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006805
Page 75 of 153
***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: 44442278 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: [ ]
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006806
Page 76 of 153
***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: 44442278 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
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006807
Page 77 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 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
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006808
Page 78 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 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
Name Signature
MeaningDate Type Action
Yanina
Rivera Approved Mar-12-2021 17:00:37 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, YaninaRivera, 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.
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006809
Page 79 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-28-2020 10:44:40 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006810
Page 80 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 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
Name Signature
MeaningDate Type Action
Yanina
Rivera Approved Mar-12-2021 17:00:37 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, YaninaRivera, 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 Mar-12-2021 11:59:23 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Yanina
Rivera Approved Mar-10-2021 22:50:51 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006811
Page 81 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, YaninaRivera, 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 Mar-02-2021 13:42:03 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-18-2021 17:15:30 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006812
Page 82 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 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.
Agustin
Morato
Cabral N/A Feb-18-2021 12:43:13 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-09-2021 10:29:23 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006813
Page 83 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 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 Feb-04-2021 16:28:34 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Santiago
Corradetti Approved Nov-14-2020 12:32:52 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006814
Page 84 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, SantiagoCorradetti, 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 11:36:22 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-10-2020 11:29:32 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006815
Page 85 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 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.
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006816
Page 86 of 153
***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: 44442278 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-28-2020
10:43:25
(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-28-2020
10:43:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006817
Page 87 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-28-2020
10:43:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent
Obtained
Sep/27/2020Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006818
Page 88 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-27-2020
17:03:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
44442278Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-27-2020
17:03:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1977Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-28-2020
10:44:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-28-2020
10:44:00ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006819
Page 89 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresO(A) OR OF SPANIS
H ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-28-2020
10:44:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006820
Page 90 of 153
***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: 44442278 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-28-2020
10:44:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/27/2020Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006821
Page 91 of 153
***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: 44442278 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-28-2020
10:45:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-28-2020
10:45:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-28-2020
10:45:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006822
Page 92 of 153
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Sep-28-2020
10:45:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:Arterial h
ypertensi
on
Start Date: Sep/1/201
3
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-28-2020
10:45:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020
10:45:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Arterial hypertensionInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006823
Page 93 of 153
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.a Start Date:
Date Location User Value Reason
Sep-28-2020
10:45:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/1/2013Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-28-2020
10:45:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-30-2020
11:25:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:obesity
Start Date: Jan/10/
2018
Ongoing: YESInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006824
Page 94 of 153
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.b Line/MH Number:
Date Location User Value Reason
Oct-30-2020
11:25:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-30-2020
11:25:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
obesityInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-30-2020
11:25:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/10/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-30-2020
11:25:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1006825
Page 95 of 153
***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: 44442278 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-28-2020
10:45:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
The subject is NOT kn
own to be HIV POSIT
IVEInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006826
Page 96 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Sep-28-2020
10:46:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-28-2020
10:46:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
132.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-28-2020
10:46:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-28-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1006827
Page 97 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
10:46:34
(UTC-03:00) City
of Buenos Aires179.0
5. Unit:
Date Location User Value Reason
Sep-28-2020
10:46:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-28-2020
10:46:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
41.2Initial Entry
7.a
Date Location User Value Reason
Sep-28-2020
10:46:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatur
e:37.0
Temperatur
e Unit:CInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1006828
Page 98 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Temperatur
e Location::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-28-2020
10:46:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-28-2020
10:46:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-28-2020
10:46:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006829
Page 99 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-28-2020
10:46:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006830
Page 100 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-28-2020
10:46:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-28-2020
10:46:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
101061Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006831
Page 101 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020
10:47:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020
10:47:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020
11:15:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-28-2020
10:47:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006832
Page 102 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Sep-28-2020
10:47:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/27/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020
11:15:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BRVFL
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-28-2020
11:15:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BRVFLCInitial Entry
5.b
Date Location User Value Reason
Sep-28-2020
11:58:22
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
Sample I BPXJMInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006833
Page 103 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires D: K
5.b Sample ID
Date Location User Value Reason
Sep-28-2020
11:58:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPXJMKInitial Entry
5.c
Date Location User Value Reason
Sep-29-2020
08:42:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID
:BRVFK
5Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-29-2020
08:42:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BRVFK5Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006834
Page 104 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020
10:47:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020
10:47:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020
12:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-28-2020
10:47:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006835
Page 105 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Sep-28-2020
10:47:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/27/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020
12:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPWSM
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-28-2020
12:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPWSMMInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006836
Page 106 of 153
***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: 44442278 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-28-2020
10:47:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020
10:47:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020
10:47:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-28-2020
10:47:54ACV0PFEINFP6000 Data Entry:
Sep/27/2020 17:08Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006837
Page 107 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Sep-28-2020
10:47:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-28-2020
10:47:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-28-2020
10:47:54
(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-28-2020
10:47:54ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006838
Page 108 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-28-2020
10:47:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006839
Page 109 of 153
***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: 44442278 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-28-2020
10:48:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENIC
ITY E-DIARY NOT C
OLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006840
Page 110 of 153
***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: 44442278 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
03:16:53
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Closed As per site
confirmation -
updated PD
tracker
Oct-16-2020
14:47:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Answere
dThe original
value is
correct.
According to
the protocol,
the subject is
not out of the
window, day 1
is the same day
as the first
dose (visit 2 is
19 days from
visit 1)
Oct-16-2020
09:04:41
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Sandip
Namdeorao
SuryawanshiQuery 1: Opened PDQ: DOV at
this visit is out
of window (-1
day) from
DOV (27/Sep
/2020) at
V1D1VX1L.
Please
reconcile and
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006841
Page 111 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
update
accordingly,
else confirm
date is correct
as is.
Oct-15-2020
16:44:05
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006842
Page 112 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Oct-15-2020
16:44:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
2.a
Date Location User Value Reason
Oct-15-2020
16:44:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.7
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-15-2020
16:44:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006843
Page 113 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
2.a Temperature:
Date Location User Value Reason
Oct-15-2020
16:44:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-15-2020
16:44:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-15-2020
16:44:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006844
Page 114 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020
16:44:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020
16:44:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
18:40:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-15-2020
16:44:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006845
Page 115 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Oct-15-2020
16:44:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020
18:40:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample I
D:BKNZJ
JInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020
18:40:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BKNZJJInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006846
Page 116 of 153
***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: 44442278 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-15-2020
16:45:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-15-2020
16:45:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-15-2020
16:45:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-15-2020
16:45:05ACV0PFEINFP6000 Data Entry:
Oct/15/2020 15:27Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006847
Page 117 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Oct-15-2020
16:45:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-15-2020
16:45:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-15-2020
16:45:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-15-2020
16:45:05ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1006848
Page 118 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-15-2020
16:45:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006849
Page 119 of 153
***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: 44442278 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
13:06:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006850
Page 120 of 153
***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: 44442278 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
13:07:08
(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
13:07:08
(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
17:04:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-13-2020
13:07:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006851
Page 121 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Nov-13-2020
13:07:08
(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
17:04:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BRVS8
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-13-2020
17:04:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BRVS8BInitial Entry
5.b
Date Location User Value Reason
Nov-13-2020
17:12:57
(UTC-03:00) CityACV0PFEINFP6000 Alan Colombo Data Entry:
Sample I BRVS8Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006852
Page 122 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires D: N
5.b Sample ID
Date Location User Value Reason
Nov-13-2020
17:12:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BRVS8NInitial Entry
5.c
Date Location User Value Reason
Nov-13-2020
17:24:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample I
D:BPTB5
NInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-13-2020
17:24:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BPTB5NInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006853
Page 123 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Nov-13-2020
11:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006854
Page 124 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Mar-12-2021
11:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006855
Page 125 of 153
***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, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Nov-13-2020
11:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-13-2020
11:36:22
(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
Nov-13-2020
11:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
FeverInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-13-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1006856
Page 126 of 153
***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, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
11:36:22
(UTC-03:00) City
of Buenos AiresOct/16/2020 11:07
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-13-2020
11:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/17/2020 20:06Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-13-2020
11:36:22
(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
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006857
Page 127 of 153
***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, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nov-13-2020
11:36:22
(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
Nov-13-2020
11:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-13-2020
11:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-13-2020
11:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006858
Page 128 of 153
***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, Locked, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Nov-13-2020
11:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-13-2020
11:36:22
(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
Nov-13-2020
11:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-13-2020
11:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006859
Page 129 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Mar-12-2021
11:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-12-2021
11:59:23
(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
Mar-12-2021
11:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Hypertensive urgencyInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006860
Page 130 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Mar-12-2021
11:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/4/2021 20:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-12-2021
11:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Mar/4/2021 20:30Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-12-2021
11:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial 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
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006861
Page 131 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Mar-12-2021
11:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
Hypertensive
urgency:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Mar-12-2021
11:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event
associated with con
genital anomaly or
birth defect?
NO
Did this serious eve
nt result in death?
NO
Did this serious eve
nt require or prolon
g hospitalization?
NO
Did this serious eve
nt result in persisteInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006862
Page 132 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
nt or significant dis
ability/incapacity?
NO
Is this serious event
life threatening?
NO
Other medically im
portant serious eve
nt
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-12-2021
11:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-12-2021
11:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), thisInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006863
Page 133 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
event is due to:
OTHER
If Other, specify:
Worsening of hi
gh blood pressur
e
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-12-2021
11:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-12-2021
11:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-12-2021
11:59:23ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006864
Page 134 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-12-2021
11:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-12-2021
11:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006865
Page 135 of 153
***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: 44442278 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
13:07:24
(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
13:07:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-13-2020
13:07:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006866
Page 136 of 153
***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: 44442278 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-04-2021
16:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/4/2021Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006867
Page 137 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-04-2021
16:28:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Feb/4/2021Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006868
Page 138 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-04-2021
16:29:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-04-2021
16:29:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-05-2021
17:40:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-05-2021
00:54:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006869
Page 139 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Feb-04-2021
16:29:05
(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-04-2021
16:29:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Feb/4/2021Initial Entry
5.a
Date Location User Value Reason
Feb-05-2021
17:40:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BNTTH
HInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-05-2021
17:40:54ACV0PFEINFP6000 Data Entry:
BNTTHHInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006870
Page 140 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
5.b
Date Location User Value Reason
Feb-06-2021
08:49:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPWD3
WInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-06-2021
08:49:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPWD3WInitial Entry
5.c
Date Location User Value Reason
Feb-06-2021
08:53:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BNTTH
7Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006871
Page 141 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.c Sample ID
Date Location User Value Reason
Feb-06-2021
08:53:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BNTTH7Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006872
Page 142 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-04-2021
17:38:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-04-2021
17:38:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-05-2021
15:25:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-05-2021
00:54:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006873
Page 143 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Feb-04-2021
17:38:40
(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.
Feb-04-2021
17:38:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Feb/4/2021Initial Entry
5.a
Date Location User Value Reason
Feb-05-2021
15:25:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Sample I
D:BHXGN
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-05-2021
15:25:38ACV0PFEINFP6000 Agustin
MoratoData Entry:
BHXGNDInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006874
Page 144 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresCabral
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006875
Page 145 of 153
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/17/2021Form: 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: 44442278 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-18-2021
12:43:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Feb/17/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-18-2021
12:43:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
SSWAB_WEEK2Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006876
Page 146 of 153
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/17/2021Form: 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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-18-2021
12:43:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-18-2021
12:43:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-18-2021
12:43:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-18-2021
12:43:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006877
Page 147 of 153
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/17/2021Form: 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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Feb-18-2021
12:43:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
YES
Date of Collection
:
Feb/17/2021Initial Entry
5.a
Date Location User Value Reason
Feb-18-2021
12:43:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Sample I
D:BR1ML
3Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-18-2021
12:43:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
BR1ML3Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006878
Page 148 of 153
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/01/2021Form: 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: 44442278 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-02-2021
13:42:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Mar/1/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Mar-02-2021
13:42:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
SSWAB_WEEK4Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006879
Page 149 of 153
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/01/2021Form: 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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-02-2021
13:42:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-02-2021
13:42:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-02-2021
14:57:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-02-2021
13:42:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006880
Page 150 of 153
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/01/2021Form: 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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Mar-02-2021
13:42:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
YES
Date of Collection
:
Mar/1/2021Initial Entry
5.a
Date Location User Value Reason
Mar-02-2021
14:57:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BR20N
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-02-2021
14:57:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BR20NFInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006881
Page 151 of 153
***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: 44442278 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
13:07:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-28-2020
10:46:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-28-2020
10:45:01
(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
13:07:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/13/2020Initial Entry
Sep-28-2020
10:46:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/27/2020Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006882
Page 152 of 153
***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: 44442278 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-28-2020
10:45:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/27/2020Initial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006883
Page 153 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44442278 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
11:29:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f0b\Final\Final On: 01-Apr-2021 03:31 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006884