Document text
Page 1 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878901
Page 2 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/25/2020
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878902
Page 3 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Demography
1.Subject ID [12313884]
2.Birth Date: /1987
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878903
Page 4 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878904
Page 5 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878905
Page 6 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878906
Page 7 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878907
Page 8 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
2.Weight: [88.0]
3.Unit: kg
4.Height: [171.0]
5.Unit: cm
6.Body Mass Index: [30.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878908
Page 9 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/25/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878909
Page 10 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/25/2020
2.Randomization Number: [65560]
3.Randomization Group: [ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878910
Page 11 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP24YJ]
5.bSample ID [BP24YK]
5.cSample ID [BP24YL]
5.dSample ID [BLDZFD]
5.eSample ID [BLDZFF]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878911
Page 12 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP2F4D]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878912
Page 13 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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/25/2020 12:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878913
Page 14 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878914
Page 15 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878915
Page 16 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878916
Page 17 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/16/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878917
Page 18 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP2B7R]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878918
Page 19 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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/16/2020 09:42
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878919
Page 20 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878920
Page 21 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
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 [BRXRV5]
5.bSample ID [BP1NFJ]
5.cSample ID [BRXRW1]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878921
Page 22 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/20/2021
2.Erroneous Visit
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878922
Page 23 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/20/2021
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 [BR1YLD]
5.bSample ID [BS1P57]
5.cSample ID [BS1TXN]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878923
Page 24 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878924
Page 25 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878925
Page 26 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878926
Page 27 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878927
Page 28 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/27/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878928
Page 29 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/27/2020
2.Date of First Symptom
Started:Sep/25/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/1/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878929
Page 30 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [rhinorrhea]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878930
Page 31 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
1.Sep/26/
2020 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878931
Page 32 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/26/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASOPHARYNX
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878932
Page 33 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[sample collected by team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878933
Page 34 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/27/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWSKB ]
5.bSample ID [BPWSKB]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878934
Page 35 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878935
Page 36 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878936
Page 37 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878937
Page 38 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878938
Page 39 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 1
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878939
Page 40 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1. Repeating
Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878940
Page 41 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878941
Page 42 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1. Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878942
Page 43 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878943
Page 44 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
1. Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878944
Page 45 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878945
Page 46 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878946
Page 47 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878947
Page 48 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878948
Page 49 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878949
Page 50 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1. Repeating
Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878950
Page 51 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: OXYGENATION PARAMETERS
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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878951
Page 52 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878952
Page 53 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878953
Page 54 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1. Repeating
Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878954
Page 55 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878955
Page 56 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/30/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878956
Page 57 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/30/2020Form: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/30/2020
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 [BPWDPP]
5.bSample ID [BJ5N9B]
5.cSample ID [BJ5NC2]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878957
Page 58 of 198
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878958
Page 59 of 198
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unplanned Assessments
1.Assessments
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878959
Page 60 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878960
Page 61 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878961
Page 62 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878962
Page 63 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878963
Page 64 of 198
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878964
Page 65 of 198
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878965
Page 66 of 198
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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:
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878966
Page 67 of 198
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878967
Page 68 of 198
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878968
Page 69 of 198
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878969
Page 70 of 198
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878970
Page 71 of 198
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878971
Page 72 of 198
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878972
Page 73 of 198
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878973
Page 74 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878974
Page 75 of 198
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878975
Page 76 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#CategoryAE Ide
ntifierAdverse Even
tStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 right axillary a
denopathy Sep/18/202
0 12:00 NO
End Date Time:
Sep/22/2020 17:00
Repeating
Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878976
Page 77 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[right axillary adenopathy]
4.Start Date Time: Sep/18/2020 12:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/22/2020 17:00
6.Toxicity Grade: 1
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878977
Page 78 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878978
Page 79 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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[ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878979
Page 80 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878980
Page 81 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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[ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878981
Page 82 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878982
Page 83 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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: //
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878983
Page 84 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878984
Page 85 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878985
Page 86 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878986
Page 87 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878987
Page 88 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878988
Page 89 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878989
Page 90 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878990
Page 91 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878991
Page 92 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878992
Page 93 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878993
Page 94 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878994
Page 95 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/14/2020
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878995
Page 96 of 198
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878996
Page 97 of 198
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878997
Page 98 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-25-2020 15:00:39
(UTC-03:00) City of Buenos AiresNot Applicable
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0878998
Page 99 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-25-2020 15:01:04
(UTC-03:00) City of Buenos AiresNot Applicable
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0878999
Page 100 of 198
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
Martina
Davalli N/A Mar-20-2021 13:09:36 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-20-2021 20:44:08 (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.
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879000
Page 101 of 198
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
N/A Jan-19-2021 13:39:49 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-03-2020 17:21:24 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Nov-03-2020 09:05:45 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-31-2020 13:18:27 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879001
Page 102 of 198
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I, FernandoPolack, 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.
Alan
Colombo N/A Oct-30-2020 18:25:56 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-30-2020 18:11:53 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879002
Page 103 of 198
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Oct-30-2020 13:45:58 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-23-2020 14:41:14 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0879003
Page 104 of 198
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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.
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879004
Page 105 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-25-2020
14:59:04
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
24 JUL 2020Transcription
Error
Aug-25-2020
14:58:51
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-25-2020
14:58:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879005
Page 106 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-25-2020
14:59:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Con
sent Obtained
Aug/25/2020Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879006
Page 107 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-25-2020
12:21:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12313884Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-25-2020
12:20:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1987Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-25-2020
14:59:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-25-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879007
Page 108 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
14:59:24
(UTC-03:00) City
of Buenos AiresHISPANIC OR LA
TINO(A) OR OF S
PANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-25-2020
14:59:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879008
Page 109 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-25-2020
14:59:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879009
Page 110 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-25-2020
15:00:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020
15:00:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-25-2020
15:00:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879010
Page 111 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020
15:01:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020
15:01:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
88.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020
15:01:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879011
Page 112 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-25-2020
15:01:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
171.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020
15:01:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-25-2020
15:01:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.1Initial Entry
7.a
Date Location User Value Reason
Aug-25-2020
15:01:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record I
dentifier:
:1
Temperat
ure:37.0Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879012
Page 113 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Temperat
ure Unit:C
Temperat
ure Locat
ion::ORAL
CAVI
TY
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020
15:01:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020
15:01:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020
15:01:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879013
Page 114 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020
15:01:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879014
Page 115 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-25-2020
15:01:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-25-2020
15:01:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-25-2020
15:01:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879015
Page 116 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-25-2020
15:01:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-25-2020
15:01:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-25-2020
15:01:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879016
Page 117 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Aug-25-2020
15:01:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-25-2020
15:01:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropi
n Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-25-2020
15:01:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879017
Page 118 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-25-2020
15:01:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020
15:01:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
65560Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879018
Page 119 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020
15:01:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020
15:01:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020
09:01:57
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-25-2020
16:22:20
(UTC-03:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879019
Page 120 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
City of Buenos
Airesno barcodes
are entered.
Please review
and correct as
appropriate.
Aug-25-2020
15:01:55
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-25-2020
15:01:55
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collecti
on:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020
09:01:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP24YJInitial Entry
5.a Sample ID
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879020
Page 121 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Aug-26-2020
09:01:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BP24YJInitial Entry
5.b
Date Location User Value Reason
Aug-26-2020
09:02:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BP24Y
KInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-26-2020
09:02:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BP24YKInitial Entry
5.c
Date Location User Value Reason
Aug-26-2020
09:02:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BP24Y
LInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879021
Page 122 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c Sample ID
Date Location User Value Reason
Aug-26-2020
09:02:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BP24YLInitial Entry
5.d
Date Location User Value Reason
Aug-26-2020
11:27:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample I
D:BLDZF
DInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-26-2020
11:27:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BLDZFDInitial Entry
5.e
Date Location User Value Reason
Aug-26-2020
11:27:32
(UTC-03:00) CityACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID
:BLDZF
FInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879022
Page 123 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
of Buenos Aires
5.e Sample ID
Date Location User Value Reason
Aug-26-2020
11:27:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BLDZFFInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879023
Page 124 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020
15:02:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020
15:02:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020
19:05:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-25-2020
16:22:20
(UTC-03:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879024
Page 125 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
City of Buenos
Airesno barcodes
are entered.
Please review
and correct as
appropriate.
Aug-25-2020
15:02:02
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-25-2020
15:02:02
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collecti
on:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020
19:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample I
D:BP2F4
DInitial Entry
5.a Sample ID
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879025
Page 126 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Aug-26-2020
19:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BP2F4DInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879026
Page 127 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-25-2020
15:02:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020
15:02:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020
15:02:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-25-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879027
Page 128 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
15:02:15
(UTC-03:00) City
of Buenos AiresAug/25/2020 12:5
0
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020
15:02:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-25-2020
15:02:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-25-2020
15:02:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879028
Page 129 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-25-2020
15:02:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-25-2020
15:02:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879029
Page 130 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-25-2020
15:02:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTE
D FOR THIS SUB
JECTInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879030
Page 131 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-17-2020
15:50:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879031
Page 132 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020
15:51:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020
15:51:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.8
Temperatur
e Unit:C
Temperatur
e Location:
:ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-17-2020
15:51:02
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879032
Page 133 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
of Buenos Aires
2.a Temperature:
Date Location User Value Reason
Sep-17-2020
15:51:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-17-2020
15:51:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-17-2020
15:51:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879033
Page 134 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-17-2020
15:51:14
(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
15:51:14
(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
15:51:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879034
Page 135 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-17-2020
15:51:14
(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
15:51:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-17-2020
15:51:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879035
Page 136 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Sep-17-2020
15:51:14
(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
15:51:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-17-2020
15:51:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879036
Page 137 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020
12:29:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020
12:29:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020
12:29:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-16-2020
12:29:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879037
Page 138 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
are entered.
Please review
and correct as
appropriate.
Sep-16-2020
12:29:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020
12:29:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID
:BP2B7
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020
12:29:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BP2B7RInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879038
Page 139 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-17-2020
15:51:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020
15:51:44
(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
15:51:44
(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 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0879039
Page 140 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
15:51:44
(UTC-03:00) City
of Buenos AiresSep/16/2020 09:42
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020
15:51:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-17-2020
15:51:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-17-2020
15:51:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879040
Page 141 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-17-2020
15:51:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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
15:51:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879041
Page 142 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020
19:05:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0879042
Page 143 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
12:36:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
12:36:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020
12:36:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-14-2020
12:36:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879043
Page 144 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
12:36:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020
12:36:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BRXRV
5Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020
12:36:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BRXRV5Initial Entry
5.b
Date Location User Value Reason
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879044
Page 145 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-14-2020
13:11:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Sample ID
:BP1NF
JInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-14-2020
13:11:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
BP1NFJInitial Entry
5.c
Date Location User Value Reason
Oct-14-2020
13:55:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BRXRW
1Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-14-2020
13:55:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BRXRW1Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879045
Page 146 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-20-2021
13:09:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Mar/20/2021Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879046
Page 147 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-20-2021
13:09:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-20-2021
13:09:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-20-2021
16:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-20-2021
13:09:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879047
Page 148 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
are entered.
Please review
and correct as
appropriate.
Mar-20-2021
13:09:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection
:
Mar/20/2021Initial Entry
5.a
Date Location User Value Reason
Mar-20-2021
16:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BR1YL
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-20-2021
16:59:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BR1YLDInitial Entry
5.b
Date Location User Value Reason
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879048
Page 149 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Mar-20-2021
17:18:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BS1P5
7Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-20-2021
17:18:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BS1P57Initial Entry
5.c
Date Location User Value Reason
Mar-20-2021
17:35:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BS1TX
NInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-20-2021
17:35:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BS1TXNInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879049
Page 150 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Sep-28-2020
09:10:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-27-2020
18:43:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms
form is
missing.
Please review
and update as
appropriate.
Sep-27-2020
18:43:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of
Collection in
both Nasal
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879050
Page 151 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Swab Self and
Nasal Swab
are missing.
Please review
and update as
appropriate.
Sep-27-2020
18:43:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/27/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Sep-27-2020
18:43:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879051
Page 152 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/27/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Nov-03-2020
12:55:03
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-03-2020
09:05:45
(UTC-03:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dNew
Information
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879052
Page 153 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
City of Buenos
Aires
Nov-03-2020
09:05:45
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NO
Date of Last Sy
mptom Resolved
:
Oct/1/2020New
Information
Nov-02-2020
23:56:46
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Opened DM:
Convalescent
visit occurred
but Date of
Last Symptom
Resolved is
missing. Please
confirm
symptoms are
still ongoing. If
symptoms have
resolved
update
response for
Symptom
ongoing as 'No'
and add date
resolved.
Sep-28-2020
13:42:12
(UTC-03:00)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879053
Page 154 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
City of Buenos
Aires
4.a
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: FEVE
R
Symptom Pre
sent:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879054
Page 155 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED
COUGH
Sympt
om Pre
sent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASE
D COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Sep-28-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879055
Page 156 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
13:42:12
(UTC-03:00) City
of Buenos AiresSymp
toms:NEW OR INC
REASED SH
ORTNESS OF
BREATH
Symp
tom P
resen
t:NO
4.c Symptoms:
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASE
D SHORTNESS OF B
REATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Sep-28-2020
13:42:12ACV0PFEINFP6000 Data Entry:
Symptoms: CHILInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0879056
Page 157 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00) City
of Buenos AiresLS
Symptom Pr
esent:NO
4.d Symptoms:
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE PA
INInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879057
Page 158 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sympt
om Pr
esent:NO
4.e Symptoms:
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASE
D MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pre
sent:NOInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879058
Page 159 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.f Symptoms:
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW LOSS OF TAS
TE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THROA
T
Sympt
om Pr
esent:YESInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879059
Page 160 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.g Symptoms:
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASE
D SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: DIARR
HEA
Symptom P
resent:NOInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879060
Page 161 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.h Symptoms:
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: VOMIT
ING
Symptom P
resent:NOInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879061
Page 162 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.i Symptoms:
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Sep-28-2020
13:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Sep-28-2020
13:43:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms -
Other:rhinorr
heaInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Sep-28-2020
13:43:01
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
rhinorrheaInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879062
Page 163 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
of Buenos Aires
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879063
Page 164 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Sep-30-2020
14:27:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879064
Page 165 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Sep-30-2020
14:32:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/26/2020Transcription
Error
Sep-30-2020
14:27:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/27/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Sep-30-2020
14:27:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERI
ALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Sep-30-2020
14:27:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879065
Page 166 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4. Assay Code and Description:
Date Location User Value Reason
Sep-30-2020
14:27:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Sep-30-2020
14:27:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGN
OSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Sep-30-2020
14:27:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ATILA BIOSYSTEM
S IAMP COVID-19 D
ETECTION KITInitial Entry
7. Test Result:
Date Location User Value Reason
Sep-30-2020
14:27:55
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879066
Page 167 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
of Buenos Aires
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879067
Page 168 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020
14:28:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020
14:28:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-30-2020
14:28:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879068
Page 169 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-30-2020
14:28:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
sample collected by te
am physicianInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879069
Page 170 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020
09:10:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020
09:10:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020
09:11:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-28-2020
09:10:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879070
Page 171 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
are entered.
Please review
and correct as
appropriate.
Sep-28-2020
09:10:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Sep/27/2020Initial Entry
5.a
Date Location User Value Reason
Sep-27-2020
18:44:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPWSK
BTranscription
Error
(DELETED)
Sep-27-2020
18:43:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPWSK
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-27-2020
18:44:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPWSKBTranscription
Error
(DELETED)
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879071
Page 172 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-27-2020
18:43:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPWSKBInitial Entry
5.b
Date Location User Value Reason
Sep-28-2020
09:11:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPWSK
BInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-28-2020
09:11:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPWSKBInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879072
Page 173 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Pract
itioner:SPEC
IALIS
T
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-02-2020
11:35:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0879073
Page 174 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-01-2020
12:49:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Answered The form was
completed.
Thank you
Sep-30-2020
20:35:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened please
complete this
page with
available
information
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Pr
actitioner:EMERG
ENCY
ROOM
Occurrenc
e of Visits o
r Contacts:NOInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879074
Page 175 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of P
ractitione
r:PRIMAR
Y CARE
PHYSICI
AN
Occurren
ce of Visit
s or Cont
acts:NOInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879075
Page 176 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
PRIMARY CARE PH
YSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Prac
titioner:URGE
NT C
ARE
Occurrence
of Visits or
Contacts:NOInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879076
Page 177 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of P
ractitione
r:TELEPH
ONE CO
NSULTA
TION
Occurren
ce of Visit
s or Cont
acts:NOInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879077
Page 178 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
TELEPHONE CONS
ULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:OT
HE
R
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879078
Page 179 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-30-2020
14:28:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Oct-01-2020
12:49:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879079
Page 180 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Sep/27/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Sep-30-2020
14:28:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-
19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Sep-30-2020
14:28:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Sep-30-2020
14:28:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879080
Page 181 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/30/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-30-2020
13:45:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/30/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-30-2020
13:45:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879081
Page 182 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/30/2020Form: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020
13:46:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020
13:46:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020
17:40:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-30-2020
13:46:13
(UTC-03:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879082
Page 183 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/30/2020Form: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
City of Buenos
Airesno barcodes
are entered.
Please review
and correct as
appropriate.
Oct-30-2020
13:46:13
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collecti
on:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-30-2020
17:40:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample I
D:BPWDP
PInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-30-2020
17:40:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BPWDPPInitial Entry
5.b
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879083
Page 184 of 198
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Oct/30/2020Form: 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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Oct-30-2020
18:09:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample I
D:BJ5N9
BInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-30-2020
18:09:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BJ5N9BInitial Entry
5.c
Date Location User Value Reason
Oct-30-2020
18:25:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample I
D:BJ5NC
2Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-30-2020
18:25:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BJ5NC2Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879084
Page 185 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-14-2020
19:06:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020
19:06:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020
19:06:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0879085
Page 186 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021
13:39:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879086
Page 187 of 198
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-19-2021
13:41:10
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Delete
dClose Auto
Query
Jan-19-2021
13:39:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candid
ateThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-19-2021
13:39:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Participant is wi
lling to return fo
r Vaccination 3
Participant is:
eligible and
NOT confirmInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879087
Page 188 of 198
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
ed to have re
ceived only p
lacebo at Vac
cination 1/2
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879088
Page 189 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Oct-12-2020
08:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879089
Page 190 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Oct-12-2020
08:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-12-2020
08:16:03
(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
Oct-12-2020
08:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
right axillary adenopa
thyInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879090
Page 191 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-12-2020
08:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/18/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-12-2020
08:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/22/2020 17:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-12-2020
08:16:03
(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).
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879091
Page 192 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Oct-12-2020
08:16:03
(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
Oct-12-2020
08:16:03
(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-12-2020
08:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
UnknownInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879092
Page 193 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-12-2020
08:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-12-2020
08:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-12-2020
08:16:03
(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
Oct-12-2020
08:16:03
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879093
Page 194 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
of Buenos Aires
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-12-2020
08:16:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879094
Page 195 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-19-2021
13:41:10
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-19-2021
13:41:10
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBI
LITY FOR ADDI
TIONAL VACCIN
ATIONInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879095
Page 196 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-14-2020
19:06:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-25-2020
15:01:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-25-2020
15:00:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-14-2020
19:06:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
Aug-25-2020
15:01:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879096
Page 197 of 198
***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: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-25-2020
15:00:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879097
Page 198 of 198
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12313884 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020
21:40:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2e8f\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879098