Document text
Page 1 of 280
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003718
Page 2 of 280
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/22/2020
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003719
Page 3 of 280
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Demography
1.Subject ID [44441470]
2.Birth Date: /1951
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003720
Page 4 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003721
Page 5 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003722
Page 6 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003723
Page 7 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003724
Page 8 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003725
Page 9 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
2.Weight: [88.0]
3.Unit: kg
4.Height: [169.0]
5.Unit: cm
6.Body Mass Index: [30.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003726
Page 10 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/22/2020
2.Randomization Number: [263838]
3.Randomization Group: [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003727
Page 11 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
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 [BRVL8Y]
5.bSample ID [BPXHRS]
5.cSample ID [BRVL98]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003728
Page 12 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
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 [BPWTBG]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003729
Page 13 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/22/2020 17:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003730
Page 14 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003731
Page 15 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003732
Page 16 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Oct/13/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003733
Page 17 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1V77]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003734
Page 18 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/13/2020 12:22
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003735
Page 19 of 280
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003736
Page 20 of 280
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/12/2020
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 [BJ4F86]
5.bSample ID [BJ4F8G]
5.cSample ID [BP1PV7]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003737
Page 21 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003738
Page 22 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/2/2021
2.Date of First Symptom Started: Jan/29/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/2/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
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
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
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003739
Page 23 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [otalgia]
5.bSymptoms - Other Text: [nasal congestion]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003740
Page 24 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Feb/2/202
1 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003741
Page 25 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Feb/2/2021
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: [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003742
Page 26 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_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 [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003743
Page 27 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/2/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW700]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003744
Page 28 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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: YES
Number of Visits or Contacts:
[1]
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
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
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003745
Page 29 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003746
Page 30 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003747
Page 31 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003748
Page 32 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003749
Page 33 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003750
Page 34 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003751
Page 35 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003752
Page 36 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003753
Page 37 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003754
Page 38 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003755
Page 39 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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: [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003756
Page 40 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003757
Page 41 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003758
Page 42 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003759
Page 43 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003760
Page 44 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003761
Page 45 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003762
Page 46 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003763
Page 47 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003764
Page 48 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003765
Page 49 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/18/2021
2.Date of First Symptom Started: Feb/17/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/26/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
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
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003766
Page 50 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Asthenia]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003767
Page 51 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Feb/18/20
21 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003768
Page 52 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Feb/18/2021
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: [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003769
Page 53 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_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 [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003770
Page 54 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/18/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRM92X]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003771
Page 55 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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: YES
Number of Visits or Contacts:
[1]
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
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?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003772
Page 56 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Feb/20/2021 NO
Discharge Date:
Feb/26/2021
Repeating Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003773
Page 57 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Feb/20/2021
4.Ongoing? NO
Discharge Date:
Feb/26/2021
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003774
Page 58 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003775
Page 59 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003776
Page 60 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?YES
Respiratory Illness Diagnosis:
[Community acute bilateral bacterial pneumonia]
Date of Diagnosis:
Feb/20/2021
3.Toxicity Grade: 2
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(b) (4)
FDA-CBER-2021-5683-1003777
Page 61 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003778
Page 62 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003779
Page 63 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category
for Lab T
estVendor NameCollec
tion D
ate:Speci
men T
ypeLab ResultForm Insta
nce
1.CLINICA
L CHEMI
STRY Instituto Argentino de Diagnostico y
Tratamiento Marcelo Torcuato de Al
vear 2346, capital federal Feb/20
/2021 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
329 C Reactive Pr
otein_PX329 175
.97
30 Alanine Ami
notransferase
_PX30 34
28 Aspartate A
minotransfera
se_PX28 49
35 Alkaline Pho
sphatase_PX
35 79
21 Bilirubin_PX
21 0.8
1
47 Blood Urea
Nitrogen_PX
47 52
48 Creatinine_P
X48 0.9
7 Repeating
Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003780
Page 64 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Instituto Argentino de Diagnostico y Tratamiento Marcelo Torcuato de Alvear
2346, capital federal]
3.Collection Date: Feb/20/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [175.97]
Not Done:
LNMT Low
[0]
High
[5]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [34]
Not Done:
LNMT Low
[0]
High
[41]
Unit
U/L
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003781
Page 65 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [49]
Not Done:
LNMT Low
[0]
High
[40]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [79]
Not Done:
LNMT Low
[40]
High
[129]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.81]
Not Done:
LNMT Low
[0]
High
[1.2]
Unit
mg/L
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003782
Page 66 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [52]
Not Done:
LNMT Low
[16.6]
High
[48.5]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.97]
Not Done:
LNMT Low
[0.70]
High
[1.20]
Unit
mg/dL
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003783
Page 67 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category
for Lab T
estVendor Name (DERIVED)Collect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
1.HEMATO
LOGY Instituto Argentino de Diagnostico y Tr
atamiento Marcelo Torcuato de Alvear
2346, capital federal Feb/20/
2021 BLOO
D Sponsor-D
efined Iden
tifierTest:Res
ult:
1 Hemoglo
bin_PX1 15.
5
2 Hematocr
it_PX2 46.
9
3 Erythroc
ytes_PX3
[ ]
5 Platelets_
PX5 157
000
7 Leukocyt
es_PX7 [ ]
608 Neutroph
ils_PX60
8 7.1
7
609 Eosinoph
ils_PX60
9 0.0
7
612 Monocyt
es_PX61
2 0.5
6
610 Basophils
_PX610 0.0
5
611 Lymphoc
ytes_PX6
11 0.5
8 Repeating
Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003784
Page 68 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Answered Queries
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Instituto Argentino de Diagnostico y Tratamiento Marcelo Torcuato de Alvear
2346, capital federal]
3.Collection Date: Feb/20/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [15.5]
Not Done:
LNMT Low
[13.1]
High
[15.9]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [46.9]
Not Done:
LNMT Low
[40]
High
[49]
Unit
%
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003785
Page 69 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Answered Queries
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [157000]
Not Done:
LNMT Low
[150000]
High
[450000]
Unit
/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003786
Page 70 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Answered Queries
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [7.17]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
10^9/L
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.07]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
10^9/L
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.56]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
10^9/L
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003787
Page 71 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Answered Queries
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.05]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
10^9/L
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.58]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
10^9/L
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003788
Page 72 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-1003789
Page 73 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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: [ ]
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(b) (4)
FDA-CBER-2021-5683-1003790
Page 74 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003791
Page 75 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003792
Page 76 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003793
Page 77 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003794
Page 78 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003795
Page 79 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003796
Page 80 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date of Asse
ssmentLocation of Ass
essmentImaging M
ethodOverall AssessmentForm Instanc
e
1.Feb/20/2021 CHEST CT SCAN ABNORMAL
If abnormal, specify findings:
Parenchymal consolidation with anterior and lingul
ar segment air bronchogram
of the left upper lobe suggestive of an inflammator
y / infectious process,
correlate clinically.
(continue in comments)
Repeating
Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003797
Page 81 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Feb/20/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Parenchymal consolidation with anterior and lingular segment air
bronchogram
of the left upper lobe suggestive of an inflammatory / infectious
process,
correlate clinically.
(continue in comments)]Comments
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003798
Page 82 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/05/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003799
Page 83 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/05/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/5/2021
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 [BLBHHH]
5.bSample ID [BR230W]
5.cSample ID [BLBHH0]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003800
Page 84 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003801
Page 85 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003802
Page 86 of 280
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003803
Page 87 of 280
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Unplanned Assessments
1.Assessments
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003804
Page 88 of 280
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Community-acquired pn
eumonia Jan/29/2021 1
5:00 NO
End Date Time:
Mar/2/2021 20:00
Repeating
Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003805
Page 89 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Community-acquired pneumonia]
4.Start Date Time: Jan/29/2021 15:00
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/2/2021 20:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003806
Page 90 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021267660]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003807
Page 91 of 280
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003808
Page 92 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003809
Page 93 of 280
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003810
Page 94 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003811
Page 95 of 280
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003812
Page 96 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003813
Page 97 of 280
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003814
Page 98 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003815
Page 99 of 280
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003816
Page 100 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003817
Page 101 of 280
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003818
Page 102 of 280
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003819
Page 103 of 280
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003820
Page 104 of 280
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003821
Page 105 of 280
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003822
Page 106 of 280
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003823
Page 107 of 280
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003824
Page 108 of 280
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003825
Page 109 of 280
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003826
Page 110 of 280
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/12/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003827
Page 111 of 280
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003828
Page 112 of 280
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003829
Page 113 of 280
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003830
Page 114 of 280
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/5/2021
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003831
Page 115 of 280
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003832
Page 116 of 280
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Mar/5/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003833
Page 117 of 280
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Sample collected during covid B convalescence visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003834
Page 118 of 280
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/5/2021
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 [BR203S]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003835
Page 119 of 280
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/5/2021 12:19
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003836
Page 120 of 280
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003837
Page 121 of 280
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003838
Page 122 of 280
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003839
Page 123 of 280
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003840
Page 124 of 280
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003841
Page 125 of 280
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003842
Page 126 of 280
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003843
Page 127 of 280
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003844
Page 128 of 280
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003845
Page 129 of 280
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003846
Page 130 of 280
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/12/2020
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003847
Page 131 of 280
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003848
Page 132 of 280
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003849
Page 133 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-23-2020 13:19:49 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003850
Page 134 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-23-2020 13:20:21 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003851
Page 135 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Answered Queries
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormMar-12-2021 14:56:56 (UTC-03:00) City of
Buenos AiresSome Lab Normal Range are not available. We
tried multiple ways to obtain absolute values,
byut it was not possible since it is not reported
by lab this way. This information will not be
available.
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003852
Page 136 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
4Feb-28-2021 18:32:29 (UTC-03:00) City of
Buenos AiresPleural or pericardial effusion was not identified.
Preserved caliber of thoracic vascular structures.
The tracheobronchial tree with common
characteristics.
There are no mediastinal or axillary lymph
nodes.
Free supraclavicular hollows.
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003853
Page 137 of 280
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormMar-05-2021 15:33:45 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003854
Page 138 of 280
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-23-2021 11:57:54 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Tatiana Estrada Approved Feb-16-2021 17:16:43 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, TatianaEstrada, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Agustin Morato
Cabral N/A Feb-08-2021 15:15:01 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Gonzalo Perez
Marc Approved Feb-06-2021 10:33:14 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, GonzaloPerez, 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.
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003855
Page 139 of 280
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Martina Davalli N/A Feb-03-2021 17:13:52 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-13-2020 10:51:14 (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-12-2020 14:39:51 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-10-2020 11:37:24 (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.
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b)
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003856
Page 140 of 280
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-23-2020 13:19:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-23-2020 13:19:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003857
Page 141 of 280
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-23-2020 13:19:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/22/2020Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003858
Page 142 of 280
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-22-2020 16:59:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
44441470Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-22-2020 16:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1951Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-23-2020 13:19:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-23-2020 13:19:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR O
F SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-23-2020 13:19:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003859
Page 143 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-23-2020 13:19:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003860
Page 144 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-23-2020 13:20:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-23-2020 13:20:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-23-2020 13:20:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003861
Page 145 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-23-2020 13:20:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
The subject is NOT known to be H
IV POSITIVEInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003862
Page 146 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020 13:21:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-23-2020 13:21:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
88.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-23-2020 13:21:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-23-2020 13:21:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
169.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-23-2020 13:21:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-23-2020 13:21:02 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003863
Page 147 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos Aires(autocalc) 30.8
7.a
Date Location User Value Reason
Sep-23-2020 13:21:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-23-2020 13:21:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-23-2020 13:21:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-23-2020 13:21:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-23-2020 13:21:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003864
Page 148 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-23-2020 13:21:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-23-2020 13:21:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
263838Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003865
Page 149 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 13:21:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 13:21:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020 13:30:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 13:21:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-23-2020 13:21:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020 13:30:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRVL8YInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003866
Page 150 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.a Sample ID
Date Location User Value Reason
Sep-23-2020 13:30:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRVL8YInitial Entry
5.b
Date Location User Value Reason
Sep-23-2020 15:36:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BPXHRSInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-23-2020 15:36:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BPXHRSInitial Entry
5.c
Date Location User Value Reason
Sep-23-2020 16:30:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BRVL98Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-23-2020 16:30:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BRVL98Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003867
Page 151 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 13:21:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 13:21:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020 14:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 13:21:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-23-2020 13:21:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020 14:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPWTBGInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003868
Page 152 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.a Sample ID
Date Location User Value Reason
Sep-23-2020 14:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPWTBGInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003869
Page 153 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-23-2020 13:22:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020 13:22:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020 13:22:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-23-2020 13:22:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/22/2020 17:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020 13:22:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-23-2020 13:22:11 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1003870
Page 154 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos AiresLEFT
7. Route:
Date Location User Value Reason
Sep-23-2020 13:22:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-23-2020 13:22:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-23-2020 13:22:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003871
Page 155 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-23-2020 13:22:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003872
Page 156 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020 15:00:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003873
Page 157 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Oct-14-2020 15:00:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
2.a
Date Location User Value Reason
Oct-14-2020 15:00:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.8
Temperature Unit
:C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-14-2020 15:00:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-14-2020 15:00:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003874
Page 158 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-14-2020 15:00:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-14-2020 15:00:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003875
Page 159 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020 14:19:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 14:19:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 14:19:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 14:19:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-13-2020 14:19:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020 14:19:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP1V77Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003876
Page 160 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.a Sample ID
Date Location User Value Reason
Oct-13-2020 14:19:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP1V77Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003877
Page 161 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-14-2020 15:03:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-14-2020 15:03:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-14-2020 15:03:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-14-2020 15:03:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/13/2020 12:22Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-14-2020 15:03:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003878
Page 162 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-14-2020 15:03:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-14-2020 15:03:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-14-2020 15:03:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-14-2020 15:03:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003879
Page 163 of 280
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-12-2020 14:40:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/12/2020Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003880
Page 164 of 280
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-12-2020 14:39:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020 14:39:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-12-2020 14:40:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-12-2020 14:39:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-12-2020 14:39:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
Nov-12-2020 14:40:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ4F86Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003881
Page 165 of 280
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.a Sample ID
Date Location User Value Reason
Nov-12-2020 14:40:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ4F86Initial Entry
5.b
Date Location User Value Reason
Nov-12-2020 16:42:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ4F8GInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-12-2020 16:42:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ4F8GInitial Entry
5.c
Date Location User Value Reason
Nov-12-2020 18:26:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BP1PV7Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-12-2020 18:26:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BP1PV7Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003882
Page 166 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021 17:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-03-2021 17:13:50
(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.
Feb-03-2021 17:13:50
(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 Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Feb-03-2021 17:13:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Feb/2/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-03-2021 17:13:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003883
Page 167 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Feb/2/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-04-2021 15:16:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-04-2021 12:44:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Feb-04-2021 12:44:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/29/2021Initial Entry
Feb-04-2021 06:15:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: The response
for "Date of First
Symptom Started"
is missing. Kindly
review and update.
Feb-03-2021 17:28:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry: Transcription Error
Feb-03-2021 17:26:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Jan/29/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-05-2021 13:32:11
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
NONew Information
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1003884
Page 168 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires Date of Last Symptom Resol
ved:
Feb/2/2021
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina Davalli Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom
Present:NOInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003885
Page 169 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.b Symptoms:
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NEW OR INCREASED SHORT
NESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
4.d
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003886
Page 170 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAIN
Symptom
Present:NOInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003887
Page 171 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.e Symptoms:
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symptoms
:NEW LOSS OF TA
STE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NEW LOSS OF TASTE OR SM
ELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
4.g
Date Location User Value Reason
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003888
Page 172 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:YESInitial Entry
4.g Symptoms:
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symptoms: DIARRHE
A
Symptom Present
:NOInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003889
Page 173 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.h Symptoms:
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-03-2021 17:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Feb-03-2021 17:20:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symptoms - Other: otalgiaInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003890
Page 174 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.a Symptoms - Other Text:
Date Location User Value Reason
Feb-03-2021 17:20:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
otalgiaInitial Entry
5.b
Date Location User Value Reason
Feb-03-2021 17:20:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Symptoms - Oth
er:nasal congesti
onInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Feb-03-2021 17:20:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
nasal congestionInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003891
Page 175 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Feb-03-2021 17:21:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliForm Created
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003892
Page 176 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Feb-03-2021 17:21:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Feb/2/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-03-2021 17:21:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-03-2021 17:21:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Feb-03-2021 17:21:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Feb-03-2021 17:21:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-03-2021 17:21:17 ACV0PFEINFP6000 Martina Data Entry: Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003893
Page 177 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos AiresDavalli ATILA BIOSYSTEMS IAMP C
OVID-19 DETECTION KIT
7. Test Result:
Date Location User Value Reason
Feb-03-2021 17:21:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NEGATIVEInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003894
Page 178 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: 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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-03-2021 17:22:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-03-2021 17:22:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-03-2021 17:22:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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
Feb-03-2021 17:22:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
sample collected by team physici
anInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003895
Page 179 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-03-2021 17:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-03-2021 17:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-08-2021 15:15:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-04-2021 06:32:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-03-2021 17:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-03-2021 17:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Feb/2/2021Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003896
Page 180 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.a
Date Location User Value Reason
Feb-08-2021 15:15:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Sample ID: BPW700Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-08-2021 15:15:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
BPW700Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003897
Page 181 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Type of Practit
ioner:EMERGENCY
ROOM
Occurrence of
Visits or Conta
cts:YES
Number of Vis
its or Contact
s:
1Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003898
Page 182 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.c
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Conta
cts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003899
Page 183 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.d
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Type of Practitioner
:URGENT
CARE
Occurrence of Visit
s or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003900
Page 184 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits or
Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003901
Page 185 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-03-2021 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003902
Page 186 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/02/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Feb-03-2021 17:25:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNES
SInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Feb-03-2021 17:25:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Feb-03-2021 17:25:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
1Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003903
Page 187 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021 12:01:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-23-2021 11:57:52
(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.
Feb-23-2021 11:57:52
(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 Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Feb-23-2021 11:57:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/18/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-23-2021 11:57:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_BInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003904
Page 188 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/18/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/17/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-04-2021 11:53:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolved
:
Feb/26/2021New Information
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003905
Page 189 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003906
Page 190 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003907
Page 191 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.d Symptoms:
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCLE
PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003908
Page 192 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.f
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms
:NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREASE
D SORE THROAT
Symptom
Present:NOInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003909
Page 193 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.g Symptoms:
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE TH
ROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003910
Page 194 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-23-2021 11:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Feb-23-2021 12:00:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms - Other: AstheniaInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Feb-23-2021 12:00:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
AstheniaInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003911
Page 195 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Feb-23-2021 12:00:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003912
Page 196 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Feb-23-2021 12:00:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/18/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-23-2021 12:00:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-23-2021 12:00:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Feb-23-2021 12:00:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Feb-23-2021 12:00:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003913
Page 197 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Feb-23-2021 12:00:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ATILA BIOSYSTEMS IAMP CO
VID-19 DETECTION KITInitial Entry
7. Test Result:
Date Location User Value Reason
Feb-23-2021 12:00:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003914
Page 198 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: 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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-23-2021 12:01:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-23-2021 12:01:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-23-2021 12:01:00
(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
Feb-23-2021 12:01:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample collected by team physicia
nInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003915
Page 199 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-23-2021 12:01:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-23-2021 12:01:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-23-2021 15:33:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-23-2021 12:01:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-23-2021 12:01:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/18/2021Initial Entry
5.a
Date Location User Value Reason
Feb-23-2021 15:33:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRM92XInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003916
Page 200 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.a Sample ID
Date Location User Value Reason
Feb-23-2021 15:33:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRM92XInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003917
Page 201 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:EMERGENCY
ROOM
Occurrence of
Visits or Contac
ts:YES
Number of Visi
ts or Contacts:
1Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003918
Page 202 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.c
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of V
isits or Contacts
:NOInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003919
Page 203 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003920
Page 204 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.e
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Contac
ts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Feb-23-2021 12:02:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or C
ontacts:NOInitial Entry
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or C
ontacts:Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003921
Page 205 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-23-2021 12:02:38
(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
Feb-23-2021 12:01:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Has the subject been in intensive
care due to potential COVID-19 i
llness?
NOInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003922
Page 206 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Feb-23-2021 12:02:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003923
Page 207 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Feb-23-2021 12:02:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Feb-23-2021 12:02:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HOSPITALInitial Entry
3. Admission Date:
Date Location User Value Reason
Feb-25-2021 11:18:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Will e mail CRA.
Feb-24-2021 18:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered There is no more
information
available so far,
because the
participant is still
hospitalized. When
there is more
information, the data
will be updated.
Thank you
Feb-24-2021 14:55:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened CLIQUERY:
Hospitalization: This
subject had
COVID-19 Illness
and was
hospitalized. Please
enter any available
information in the
assessment CRF's in
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003924
Page 208 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
this visit. Please
make every effort to
obtain these
information.
Feb-24-2021 14:45:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Changed data per
query
Feb-24-2021 14:43:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLIQUERY:
Hospitalization: This
subject had
COVID-19 Illness
and was
hospitalized. Please
enter any available
information (vital
signs, pulse oxymet,
respiratory
treatment, lab
results, imaging…).
Please make every
effort to obtain these
information.
Feb-23-2021 12:02:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/20/2021Initial Entry
4. Ongoing?
Date Location User Value Reason
Feb-28-2021 18:12:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
Discharge Date:
Feb/26/2021New Information
Feb-23-2021 12:02:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003925
Page 209 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Feb-23-2021 12:03:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNES
SInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Feb-24-2021 14:37:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-24-2021 14:37:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness Diagnosis:
Community acute bilateral bac
terial pneumonia
Date of Diagnosis:
Feb/20/2021New Information
Feb-23-2021 12:03:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Yes is selected,
however, either the
diagnosis details or
date of diagnosis is
missing. Please
correct.
Feb-23-2021 12:03:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness Diagnosis:
Community acute bilateral bac
terial pneumoniaInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003926
Page 210 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-23-2021 12:03:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003927
Page 211 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Audit Trail
Form Version: 15-Sep-2020 21:51 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Feb-28-2021 18:15:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003928
Page 212 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-28-2021 18:15:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
CLINICAL CHEMISTRYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Feb-28-2021 18:15:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Instituto Argentino de Diagnost
ico y Tratamiento Marcelo Torc
uato de Alvear 2346, capital fe
deralInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-28-2021 18:15:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/20/2021Initial Entry
4. Specimen Type:
Date Location User Value Reason
Feb-28-2021 18:15:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Feb-28-2021 18:15:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:329
Test:: C Reactive Prot
ein_PX329
Result:: 175.97Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003929
Page 213 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Not Done::
Lab Normal Ra
nge:Low
0
High
5
Unit
mg/L
5.a Sponsor ID:
Date Location User Value Reason
Feb-28-2021 18:15:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
329Initial Entry
5.a Test:
Date Location User Value Reason
Feb-28-2021 18:15:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
C Reactive Protein_PX329Initial Entry
5.a Result:
Date Location User Value Reason
Feb-28-2021 18:15:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
175.97Initial Entry
5.a LNMT
Date Location User Value Reason
Feb-28-2021 18:15:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
0
High
5
UnitInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003930
Page 214 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
mg/L
5.b
Date Location User Value Reason
Feb-28-2021 18:21:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sponsor-Def
ined Identifi
er:30
Test:: Alanine Amino
transferase_PX
30
Result:: 34
Not Done::
Lab Normal
Range:Low
0
High
41
Unit
U/LTranscription Error
Feb-28-2021 18:21:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:30
Test:: Alanine Amino
transferase_PX
30
Result:: 34
Not Done:: NOT DONE
Lab Normal
Range:Low
0
High
41
Unit
U/LInitial Entry
Feb-28-2021 18:15:43 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1003931
Page 215 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos AiresSponsor-Defi
ned Identifie
r:
Test:: Alanine Amino
transferase_PX
30
Result::
Not Done::
Lab Normal
Range:
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1003932
Page 216 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.b Sponsor ID:
Date Location User Value Reason
Feb-28-2021 18:21:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30Initial Entry
5.b Test:
Date Location User Value Reason
Feb-28-2021 18:15:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Alanine Aminotransferase_PX3
0Initial Entry
5.b Result:
Date Location User Value Reason
Feb-28-2021 18:21:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
34Initial Entry
5.b Not Done:
Date Location User Value Reason
Feb-28-2021 18:21:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Feb-28-2021 18:21:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.b LNMT
Date Location User Value Reason
Feb-28-2021 18:21:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
0
High
41Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003933
Page 217 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Unit
U/L
5.c
Date Location User Value Reason
Feb-28-2021 18:21:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sponsor-Def
ined Identifi
er:28
Test:: Aspartate Amin
otransferase_P
X28
Result:: 49
Not Done::
Lab Normal
Range:Low
0
High
40
Unit
U/LTranscription Error
Feb-28-2021 18:21:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:28
Test:: Aspartate Amin
otransferase_P
X28
Result:: 49
Not Done:: NOT DONE
Lab Normal
Range:Low
0
High
40
Unit
U/LInitial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003934
Page 218 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-28-2021 18:15:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sponsor-Def
ined Identifi
er:
Test:: Aspartate Amin
otransferase_P
X28
Result::
Not Done::
Lab Normal
Range:Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003935
Page 219 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.c Sponsor ID:
Date Location User Value Reason
Feb-28-2021 18:21:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28Initial Entry
5.c Test:
Date Location User Value Reason
Feb-28-2021 18:15:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aspartate Aminotransferase_P
X28Initial Entry
5.c Result:
Date Location User Value Reason
Feb-28-2021 18:21:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
49Initial Entry
5.c Not Done:
Date Location User Value Reason
Feb-28-2021 18:21:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Feb-28-2021 18:21:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.c LNMT
Date Location User Value Reason
Feb-28-2021 18:21:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
0
High
40Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003936
Page 220 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Unit
U/L
5.d
Date Location User Value Reason
Feb-28-2021 18:17:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:35
Test:: Alkaline Phosp
hatase_PX35
Result:: 79
Not Done::
Lab Normal
Range:Low
40
High
129
Unit
U/LInitial Entry
Feb-28-2021 18:15:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sponsor-Defin
ed Identifier:
Test:: Alkaline Phos
phatase_PX35
Result::
Not Done::
Lab Normal R
ange:Initial Entry
090177e196ae2e70\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003937
Page 221 of 280
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/18/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.d Sponsor ID
…[truncated]