125742 S1 M5 CRF c4591001 1231 12315093

Document text

Page 1 of 148
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887263
Page 2 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/29/2020
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887264
Page 3 of 148
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Demography
1.Subject ID [12315093]
2.Birth Date: /1982
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887265
Page 4 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/29/2020
2.Erroneous Visit
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887266
Page 5 of 148
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887267
Page 6 of 148
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/29/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887268
Page 7 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887269
Page 8 of 148
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Aug/29/2020
2.Weight: [70.55]
3.Unit: kg
4.Height: [153.0]
5.Unit: cm
6.Body Mass Index: [30.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887270
Page 9 of 148
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/29/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887271
Page 10 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/29/2020
2.Randomization Number: [73374]
3.Randomization Group: [ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887272
Page 11 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/29/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTT48]
5.bSample ID [BPTT49]
5.cSample ID [BPTT4B]
5.dSample ID [BNTXN9]
5.eSample ID [BNTXNB]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887273
Page 12 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/29/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWTNZ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887274
Page 13 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/29/2020 10:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887275
Page 14 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887276
Page 15 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887277
Page 16 of 148
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887278
Page 17 of 148
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/17/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887279
Page 18 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/17/2020
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 [BPWB24]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887280
Page 19 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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/17/2020 13:04
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887281
Page 20 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887282
Page 21 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
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 [BJ5MSW]
5.bSample ID [BKVDVY]
5.cSample ID [BJ4D0Z]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887283
Page 22 of 148
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/22/2021
2.Erroneous Visit
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887284
Page 23 of 148
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/22/2021
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 [BP1WY2]
5.bSample ID [BS1VY1]
5.cSample ID [BS1PZ3]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887285
Page 24 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887286
Page 25 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887287
Page 26 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887288
Page 27 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887289
Page 28 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887290
Page 29 of 148
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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: [ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887291
Page 30 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887292
Page 31 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887293
Page 32 of 148
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887294
Page 33 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887295
Page 34 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887296
Page 35 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887297
Page 36 of 148
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887298
Page 37 of 148
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Unplanned Assessments
1.Assessments
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887299
Page 38 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887300
Page 39 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887301
Page 40 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887302
Page 41 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887303
Page 42 of 148
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887304
Page 43 of 148
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887305
Page 44 of 148
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887306
Page 45 of 148
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887307
Page 46 of 148
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887308
Page 47 of 148
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887309
Page 48 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887310
Page 49 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/8/2021
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887311
Page 50 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
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 [BPWCVC]
5.bSample ID [BRVGKC]
5.cSample ID [BS443R]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887312
Page 51 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
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 [BPXWV2]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887313
Page 52 of 148
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/18/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK2
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887314
Page 53 of 148
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/18/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/18/2021
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 [BRMDBP]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887315
Page 54 of 148
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/02/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK4
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887316
Page 55 of 148
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/02/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/2/2021
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 [BRMCXM]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887317
Page 56 of 148
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/22/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/22/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK6
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887318
Page 57 of 148
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/22/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/22/2021
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 [BP887M]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887319
Page 58 of 148
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887320
Page 59 of 148
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887321
Page 60 of 148
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Adenopathy in low left cer
vical region. Sep/19/2020
10:30 NO
End Date Time:
Sep/23/2020 09:00
 Repeating
Pages
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887322
Page 61 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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)[Adenopathy in low left cervical region.]
4.Start Date Time: Sep/19/2020 10:30
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/23/2020 09:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887323
Page 62 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887324
Page 63 of 148
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Catego
ryMedication E
rrorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887325
Page 64 of 148
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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[ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887326
Page 65 of 148
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887327
Page 66 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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: //
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887328
Page 67 of 148
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887329
Page 68 of 148
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887330
Page 69 of 148
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887331
Page 70 of 148
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887332
Page 71 of 148
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887333
Page 72 of 148
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887334
Page 73 of 148
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887335
Page 74 of 148
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Booster Dose Trigger Form
1.Select appropriate response - Will
the participant return for
consent/eligibility assessment for
the booster dose visit?
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887336
Page 75 of 148
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/2/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887337
Page 76 of 148
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887338
Page 77 of 148
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887339
Page 78 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/21/2020
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887340
Page 79 of 148
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887341
Page 80 of 148
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887342
Page 81 of 148
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-29-2020 11:43:38 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887343
Page 82 of 148
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-29-2020 11:44:10 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887344
Page 83 of 148
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-22-2021 14:24:52 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-03-2021 16:27:11 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-02-2021 13:39:43 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-19-2021 09:52:10 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887345
Page 84 of 148
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
By my dated signature below, I, JohannaSas, 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-19-2021 09:33:11 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-16-2021 17:27:50 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Martina
Davalli N/A Feb-08-2021 10:09:38 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-26-2020 20:47:26 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887346
Page 85 of 148
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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.
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887347
Page 86 of 148
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-29-2020 11:42:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-29-2020 11:42:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887348
Page 87 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-29-2020 11:42:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/29/2020Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887349
Page 88 of 148
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-29-2020 09:14:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12315093Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-29-2020 09:14:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1982Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-29-2020 13:32:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-29-2020 11:43:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-29-2020 11:43:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887350
Page 89 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-29-2020 11:43:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/29/2020Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887351
Page 90 of 148
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-29-2020 11:43:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-29-2020 11:43:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-29-2020 11:43:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887352
Page 91 of 148
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Aug-29-2020 11:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/29/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-29-2020 11:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
70.55Initial Entry
3. Unit:
Date Location User Value Reason
Aug-29-2020 11:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-29-2020 11:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
153.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-29-2020 11:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887353
Page 92 of 148
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-29-2020 11:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.1Initial Entry
7.a
Date Location User Value Reason
Aug-29-2020 11:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 36.8
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-29-2020 11:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-29-2020 11:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-29-2020 11:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887354
Page 93 of 148
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-29-2020 11:44:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887355
Page 94 of 148
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-29-2020 13:32:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-29-2020 13:32:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-29-2020 14:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Aug-29-2020 14:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-29-2020 14:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/29/2020Transcription Error
Aug-29-2020 13:32:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Collection Date,
29/Sep/2020 is a
future date relative
to when it was
entered on 29/Aug
/2020. Please
correct.
Aug-29-2020 13:32:38
(UTC-03:00) City ofACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Collection Date
29/Sep/2020 is not
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887356
Page 95 of 148
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires the same as the
Date of Visit
29/Aug/2020.
Please correct or
confirm.
Aug-29-2020 13:32:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-29-2020 13:32:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-29-2020 13:32:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-29-2020 13:32:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-29-2020 13:32:38
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887357
Page 96 of 148
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
6.a Test:
Date Location User Value Reason
Aug-29-2020 13:32:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Aug-29-2020 13:32:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887358
Page 97 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-29-2020 11:45:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/29/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-29-2020 11:45:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
73374Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887359
Page 98 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-29-2020 11:45:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-29-2020 11:45:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 11:14:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-29-2020 11:45:12
(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.
Aug-29-2020 11:45:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/29/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020 11:14:43
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887360
Page 99 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires Sample ID: BPTT48
5.a Sample ID
Date Location User Value Reason
Aug-31-2020 11:14:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPTT48Initial Entry
5.b
Date Location User Value Reason
Aug-31-2020 11:14:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPTT49Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-31-2020 11:14:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPTT49Initial Entry
5.c
Date Location User Value Reason
Aug-31-2020 11:14:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPTT4BInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-31-2020 11:14:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPTT4BInitial Entry
5.d
Date Location User Value Reason
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887361
Page 100 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-31-2020 12:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
Sample ID: BNTXN9Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-31-2020 12:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
BNTXN9Initial Entry
5.e
Date Location User Value Reason
Aug-31-2020 12:39:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
Sample ID: BNTXNBInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-31-2020 12:39:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
BNTXNBInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0887362
Page 101 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-29-2020 11:45:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-29-2020 11:45:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-30-2020 13:47:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-29-2020 11:45:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-29-2020 11:45:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/29/2020Initial Entry
5.a
Date Location User Value Reason
Aug-30-2020 13:47:26
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887363
Page 102 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires Sample ID: BPWTNZ
5.a Sample ID
Date Location User Value Reason
Aug-30-2020 13:47:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPWTNZInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887364
Page 103 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-29-2020 11:45:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-29-2020 11:45:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-29-2020 11:45:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-29-2020 11:45:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/29/2020 10:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-29-2020 11:45:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887365
Page 104 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-29-2020 11:45:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-29-2020 11:45:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-29-2020 11:45:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-29-2020 11:45:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887366
Page 105 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-29-2020 11:45:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887367
Page 106 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-17-2020 14:33:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887368
Page 107 of 148
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020 14:33:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020 14:33:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 36.9
Temperature U
nit:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-17-2020 14:33:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-17-2020 14:33:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-17-2020 14:33:48
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887369
Page 108 of 148
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
2.a Temperature Location:
Date Location User Value Reason
Sep-17-2020 14:33:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887370
Page 109 of 148
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-17-2020 14:33:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-17-2020 14:33:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-17-2020 14:33:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-17-2020 14:33:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-17-2020 14:33:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887371
Page 110 of 148
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Sep-17-2020 14:33:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-17-2020 14:33:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-17-2020 14:33:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX
113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-17-2020 14:33:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887372
Page 111 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020 14:34:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020 14:34:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 17:54:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 14:34:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-17-2020 14:34:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887373
Page 112 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-17-2020 17:54:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BPWB24Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 17:54:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPWB24Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0887374
Page 113 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-17-2020 14:34:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020 14:34:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020 14:34:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-17-2020 14:34:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020 13:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020 14:34:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887375
Page 114 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-17-2020 14:34:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-17-2020 14:34:10
(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-17-2020 14:34:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-17-2020 14:34:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887376
Page 115 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-21-2020 16:33:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887377
Page 116 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 16:33:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 16:33:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 18:03:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 16:33:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-21-2020 16:33:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020 18:03:53
(UTC-03:00) City ofACV0PFEINFP6000  Alan Colombo Data Entry: Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0887378
Page 117 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires Sample ID: BJ5MSW
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 18:03:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BJ5MSWInitial Entry
5.b
Date Location User Value Reason
Oct-21-2020 18:15:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BKVDVYInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020 18:15:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BKVDVYInitial Entry
5.c
Date Location User Value Reason
Oct-21-2020 18:29:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BJ4D0ZInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020 18:29:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BJ4D0ZInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0887379
Page 118 of 148
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-22-2021 14:24:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/22/2021Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887380
Page 119 of 148
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-22-2021 14:25:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-22-2021 14:25:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-23-2021 09:12:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-22-2021 14:25:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-22-2021 14:25:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/22/2021Initial Entry
5.a
Date Location User Value Reason
Mar-23-2021 09:12:17
(UTC-03:00) City ofACV0PFEINFP6000  Alan Colombo Data Entry: Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0887381
Page 120 of 148
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires Sample ID: BP1WY2
5.a Sample ID
Date Location User Value Reason
Mar-23-2021 09:12:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BP1WY2Initial Entry
5.b
Date Location User Value Reason
Mar-23-2021 09:52:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS1VY1Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-23-2021 09:52:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS1VY1Initial Entry
5.c
Date Location User Value Reason
Mar-23-2021 12:53:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS1PZ3Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-23-2021 12:53:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS1PZ3Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0887382
Page 121 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-21-2020 16:34:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-21-2020 16:34:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020 16:34:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887383
Page 122 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-08-2021 10:09:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Feb/8/2021Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0887384
Page 123 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-08-2021 10:10:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
OBTAINED
Date Written Consent Obtaine
d
Feb/8/2021Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0887385
Page 124 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-08-2021 10:10:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-08-2021 10:10:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-09-2021 10:38:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-09-2021 08:06:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-08-2021 10:10:20
(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-08-2021 10:10:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YES
Date of Collection:
Feb/8/2021Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0887386
Page 125 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a
Date Location User Value Reason
Feb-09-2021 10:38:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPWCVCInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-09-2021 10:38:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPWCVCInitial Entry
5.b
Date Location User Value Reason
Feb-09-2021 11:37:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRVGKCInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-09-2021 11:37:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRVGKCInitial Entry
5.c
Date Location User Value Reason
Feb-09-2021 12:25:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS443RInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887387
Page 126 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.c Sample ID
Date Location User Value Reason
Feb-09-2021 12:25:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS443RInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887388
Page 127 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-08-2021 11:20:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-08-2021 11:20:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-09-2021 10:41:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-09-2021 08:06:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-08-2021 11:20:02
(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-08-2021 11:20:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YES
Date of Collection:
Feb/8/2021Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0887389
Page 128 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a
Date Location User Value Reason
Feb-09-2021 10:41:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPXWV2Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-09-2021 10:41:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPXWV2Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887390
Page 129 of 148
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/18/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-19-2021 09:33:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/18/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-19-2021 09:33:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SSWAB_WEEK2Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887391
Page 130 of 148
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/18/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-19-2021 09:33:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-19-2021 09:33:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-19-2021 09:33:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-19-2021 09:33:27
(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-19-2021 09:33:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/18/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887392
Page 131 of 148
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/18/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Feb-19-2021 09:33:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRMDBPInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-19-2021 09:33:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRMDBPInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887393
Page 132 of 148
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/02/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-03-2021 15:37:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/2/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Mar-03-2021 15:37:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SSWAB_WEEK4Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887394
Page 133 of 148
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/02/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-03-2021 15:38:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-03-2021 15:38:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-03-2021 15:39:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-03-2021 15:38:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-03-2021 15:38:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/2/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887395
Page 134 of 148
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/02/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Mar-03-2021 15:39:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRMCXMInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-03-2021 15:39:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRMCXMInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887396
Page 135 of 148
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/22/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User ValueReason
Mar-29-2021
09:02:06
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies
query
Mar-26-2021
20:15:38
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: An
swere
dBoth visits were
performed on the
same date, which is
a perfectly allowed
procedure. Thank
you.
Mar-26-2021
08:04:16
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7879110;The
Date of Visit at
Visit at Visit
‘COVID-19
Surveillance Visit
=
SSWAB_WEEK6’
is the same as the
other Date of Visit
at Visit
‘V4MTH6’. Please
review for
duplication and
update as
appropriate.
Mar-22-2021
17:35:50
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
Mar/2
2/202
1Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0887397
Page 136 of 148
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/22/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Mar-22-2021 17:35:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SSWAB_WEEK6Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887398
Page 137 of 148
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/22/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-22-2021 17:36:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-22-2021 17:36:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-22-2021 17:36:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-22-2021 17:36:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-22-2021 17:36:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/22/2021Initial Entry
5.a
Date Location User Value Reason
Mar-22-2021 17:36:43
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887399
Page 138 of 148
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/22/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires Sample ID: BP887M
5.a Sample ID
Date Location User Value Reason
Mar-22-2021 17:36:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP887MInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887400
Page 139 of 148
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021 13:39:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/2/2021Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887401
Page 140 of 148
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-02-2021 13:40:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887402
Page 141 of 148
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Sep-27-2020 08:53:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887403
Page 142 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category:
Date Location User Value Reason
Sep-27-2020 08:53:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-27-2020 08:53:52
(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
Sep-27-2020 08:53:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Adenopathy in low left cervical r
egion.Initial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-27-2020 08:53:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/19/2020 10:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-27-2020 08:53:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/23/2020 09:00Initial Entry
6. Toxicity Grade:
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887404
Page 143 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Sep-27-2020 08:53:52
(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
Sep-27-2020 08:53:52
(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
Sep-27-2020 08:53:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-03-2020 06:49:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-02-2020 16:07:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-02-2020 16:07:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:New Information
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887405
Page 144 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
OTHER
If Other, specify:
unknown
Sep-28-2020 11:29:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: The response
for "Is this event
related to study
treatment" Is
reported as 'Not
Related', however
response for,
'Please indicate
what this event is
due to' is missing.
Kindly review and
update.
Sep-27-2020 08:53:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHERInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-27-2020 08:53:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-27-2020 08:53:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887406
Page 145 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-27-2020 08:53:52
(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
Sep-27-2020 08:53:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-27-2020 08:53:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0887407
Page 146 of 148
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-02-2021 13:39:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/2/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-02-2021 13:39:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0887408
Page 147 of 148
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-21-2020 16:34:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-29-2020 11:45:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-29-2020 11:43:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-21-2020 16:34:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
Aug-29-2020 11:45:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/29/2020Initial Entry
Aug-29-2020 11:43:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/29/2020Initial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0887409
Page 148 of 148
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-26-2020 20:47:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f12\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0887410