Document text
Page 1 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003118
Page 2 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003119
Page 3 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Demography
1.Subject ID [44441371]
2.Birth Date: /1955
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003120
Page 4 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003121
Page 5 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003122
Page 6 of 250
***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: 44441371 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: [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003123
Page 7 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Carotid obstruction]
Start Date: Nov/1/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Arterial hypertension]
Start Date: Nov/1/2014
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: Jul/1/2014
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Stroke]
Start Date: Nov/1/2014
Ongoing: NO
End Date:
Nov/1/2014
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003124
Page 8 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003125
Page 9 of 250
***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: 44441371 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: [100.0]
3.Unit: kg
4.Height: [164.0]
5.Unit: cm
6.Body Mass Index: [37.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003126
Page 10 of 250
***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: 44441371 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: [263471]
3.Randomization Group: [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003127
Page 11 of 250
***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: 44441371 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 [BRVM5M]
5.bSample ID [BRVM53]
5.cSample ID [BHXG6Z]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003128
Page 12 of 250
***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: 44441371 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 [BPWBSP]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003129
Page 13 of 250
***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: 44441371 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 13:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003130
Page 14 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003131
Page 15 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003132
Page 16 of 250
***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: 44441371 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: [36.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003133
Page 17 of 250
***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: 44441371 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 [BP1VCF]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003134
Page 18 of 250
***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: 44441371 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 17:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003135
Page 19 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003136
Page 20 of 250
***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: 44441371 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 [BP1PY9]
5.bSample ID [BNTRB2]
5.cSample ID [BNTR7P]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003137
Page 21 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/17/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003138
Page 22 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/17/2021
2.Date of First Symptom Started: Jan/15/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/4/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
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? YES
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? YES
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003139
Page 23 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003140
Page 24 of 250
***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: 44441371 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.Jan/17/20
21 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
2.Jan/20/20
21 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003141
Page 25 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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: Jan/17/2021
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: [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003142
Page 26 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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: Jan/20/2021
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: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT unknown]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003143
Page 27 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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 a team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003144
Page 28 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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:
Jan/17/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWB9N]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003145
Page 29 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003146
Page 30 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 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: 44441371 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 Jan/19/2021 NO
Discharge Date:
Jan/25/2021
Repeating Pages
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003147
Page 31 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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: Jan/19/2021
4.Ongoing? NO
Discharge Date:
Jan/25/2021
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003148
Page 32 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Treatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003149
Page 33 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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?
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003150
Page 34 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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:
[BILATERAL PNEUMONIA DUE TO COVID-19 DISEASE]
Date of Diagnosis:
Jan/20/2021
3.Toxicity Grade: 2
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003151
Page 35 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category of Clinical Event
:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003152
Page 36 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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:
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003153
Page 37 of 250
***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: 44441371 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 Sanatorio General Sarmiento de San M
iguel (Av. Pres. Juan Domingo Peron 1
796, Provincia de Buenos Aires) Jan/20
/2021 BLOO
D Sponsor-
Defined I
dentifierTest:Re
sul
t:
329 C Reactive P
rotein_PX32
9 [ ]
30 Alanine Ami
notransferas
e_PX30 [ ]
28 Aspartate A
minotransfer
ase_PX28 [ ]
35 Alkaline Pho
sphatase_PX
35 200
21 Bilirubin_P
X21 0.7
8
47 Blood Urea
Nitrogen_P
X47 0.3
8
48 Creatinine_P
X48 1.3
1 Repeating
Pages
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003154
Page 38 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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 [Sanatorio General Sarmiento de San Miguel (Av. Pres. Juan Domingo Peron
1796, Provincia de Buenos Aires)]
3.Collection Date: Jan/20/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003155
Page 39 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [200]
Not Done:
LNMT Low
[60]
High
[300]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.78]
Not Done:
LNMT Low
[0]
High
[1]
Unit
mg/dL
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003156
Page 40 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [0.38]
Not Done:
LNMT Low
[unk]
High
[unk]
Unit
g/L
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.31]
Not Done:
LNMT Low
[0.8]
High
[1.4]
Unit
mg/dL
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003157
Page 41 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category
for Lab
TestVendor Name (DERIVED)Collec
tion D
ate:Speci
men T
ypeLab ResultForm Insta
nce
1.HEMAT
OLOGY Sanatorio General Sarmiento de San Mig
uel (Av. Pres. Juan Domingo Peron 1796,
Provincia de Buenos Aires) Jan/20/
2021 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
1 Hemoglo
bin_PX1
12,
8
2 Hematoc
rit_PX2 38
3 Erythroc
ytes_PX
3 [ ]
5 Platelets
_PX5 264
000
7 Leukocy
tes_PX7 149
00
608 Neutrop
hils_PX6
08 105
79
609 Eosinop
hils_PX6
09 0
612 Monocyt
es_PX61
2 149
0
610 Basophil
s_PX610
0
611 Lympho
cytes_P
X611 283
1 Repeating
Pages
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003158
Page 42 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Sanatorio General Sarmiento de San Miguel (Av. Pres. Juan Domingo Peron
1796, Provincia de Buenos Aires)]
3.Collection Date: Jan/20/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12,8]
Not Done:
LNMT Low
[unk]
High
[unk]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [38]
Not Done:
LNMT Low
[unk]
High
[unk]
Unit
%
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003159
Page 43 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 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: [264000]
Not Done:
LNMT Low
[unk]
High
[unk]
Unit
10^9/L
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [14900]
Not Done:
LNMT Low
[unk]
High
[unk]
Unit
10^9/L
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003160
Page 44 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [10579]
Not Done:
LNMT Low
[unk]
High
[unk]
Unit
/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0]
Not Done:
LNMT Low
[unk]
High
[unk]
Unit
/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [1490]
Not Done:
LNMT Low
[unk]
High
[unk]
Unit
/uL
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003161
Page 45 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0]
Not Done:
LNMT Low
[unk]
High
[unk]
Unit
/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [2831]
Not Done:
LNMT Low
[unk]
High
[unk]
Unit
10^9/L
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003162
Page 46 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003163
Page 47 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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: [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003164
Page 48 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Date: Vital Signs Details Form Instance
1.Jan/19/2021 Record Identifier: Oxygen Saturation
1 88.0 Repeating Pages
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003165
Page 49 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/19/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [88.0]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003166
Page 50 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003167
Page 51 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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): [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003168
Page 52 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003169
Page 53 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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?
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003170
Page 54 of 250
***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: 44441371 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.Jan/19/2021 CHEST CT SCAN ABNORMAL
If abnormal, specify findings:
Bilateral pneumonia
Repeating Pages
2.Jan/19/2021 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
Bilateral pneumonia
Repeating Pages
3.Jan/25/2021 CHEST X-RAY NORMAL Repeating Pages
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003171
Page 55 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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: Jan/19/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Bilateral pneumonia]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003172
Page 56 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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: Jan/19/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Bilateral pneumonia]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003173
Page 57 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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: Jan/25/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: NORMAL
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003174
Page 58 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003175
Page 59 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/17/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRM8SS]
5.bSample ID [BS1RS5]
5.cSample ID [BS1RRH]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003176
Page 60 of 250
***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: 44441371 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:
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003177
Page 61 of 250
***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: 44441371 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 [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003178
Page 62 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003179
Page 63 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Unplanned Assessments
1.Assessments
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003180
Page 64 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#CategoryAE Identifi
erAdverse Even
tStart DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 Covid-19 Illne
ss Jan/15/2021 18:
00 NO
End Date Time:
Feb/3/2021 19:00
Repeating
Pages
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003181
Page 65 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 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)[Covid-19 Illness]
4.Start Date Time: Jan/15/2021 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/3/2021 19:00
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
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003182
Page 66 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 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:
[it is 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[2021161302]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003183
Page 67 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003184
Page 68 of 250
***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: 44441371 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[ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003185
Page 69 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003186
Page 70 of 250
***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: 44441371 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: //
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003187
Page 71 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003188
Page 72 of 250
***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: 44441371 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?
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003189
Page 73 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003190
Page 74 of 250
***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: 44441371 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?
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003191
Page 75 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003192
Page 76 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003193
Page 77 of 250
***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: 44441371 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: [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003194
Page 78 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003195
Page 79 of 250
***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: 44441371 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:
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003196
Page 80 of 250
***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: 44441371 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?
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003197
Page 81 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003198
Page 82 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003199
Page 83 of 250
***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: 44441371 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: [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003200
Page 84 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003201
Page 85 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003202
Page 86 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003203
Page 87 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003204
Page 88 of 250
***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: 44441371 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: [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003205
Page 89 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003206
Page 90 of 250
***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: 44441371 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
Feb/19/2021
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003207
Page 91 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003208
Page 92 of 250
***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: 44441371 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
:Feb/26/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003209
Page 93 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
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 [BRZ1S6]
5.bSample ID [BRZ1R9]
5.cSample ID [BR1ZY5]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003210
Page 94 of 250
***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: 44441371 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/26/2021
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 [BR20Y5]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003211
Page 95 of 250
***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: 44441371 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: Feb/26/2021 15:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003212
Page 96 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003213
Page 97 of 250
***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: 44441371 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 [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003214
Page 98 of 250
***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: 44441371 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?
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003215
Page 99 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003216
Page 100 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003217
Page 101 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003218
Page 102 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003219
Page 103 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003220
Page 104 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003221
Page 105 of 250
***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: 44441371 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: [ ]
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003222
Page 106 of 250
***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: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003223
Page 107 of 250
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003224
Page 108 of 250
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-11-2021 07:27:55 (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.
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003225
Page 109 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-22-2020 19:30:51 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003226
Page 110 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormFeb-26-2021 17:28:14 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003227
Page 111 of 250
***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, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-11-2021 07:27:55 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-08-2021 10:45:42 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-29-2021 20:40:38 (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 Jan-26-2021 12:36:24 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003228
Page 112 of 250
***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, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Tatiana Estrada Approved Jan-25-2021 18:53:47 (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.
Martina Davalli N/A Jan-23-2021 19:42:28 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Gonzalo Perez
Marc Approved Jan-22-2021 13:08:40 (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.
N/A Jan-21-2021 12:38:06 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 11:09:21 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003229
Page 113 of 250
***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, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-19-2021 12:24:57 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-13-2020 13:06:01 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-13-2020 13:05:46 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-13-2020 09:44:09 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003230
Page 114 of 250
***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, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-12-2020 19:31:41 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-12-2020 19:30:31 (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 14:54:50 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-10-2020 11:45:24 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003231
Page 115 of 250
***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, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003232
Page 116 of 250
***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: 44441371 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-22-2020 19:30:07
(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-22-2020 19:30:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003233
Page 117 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-22-2020 19:30:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Sep/22/2020Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003234
Page 118 of 250
***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: 44441371 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 13:56:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
44441371Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-22-2020 13:56:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1955Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-22-2020 19:30:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-22-2020 19:30:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-22-2020 19:30:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003235
Page 119 of 250
***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: 44441371 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-22-2020 19:30:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003236
Page 120 of 250
***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: 44441371 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-22-2020 19:31:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-22-2020 19:31:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-22-2020 19:31:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003237
Page 121 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Sep-22-2020 19:31:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Carotid obstru
ction
Start Date: Nov/1/2014
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-22-2020 19:31:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-22-2020 19:31:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Carotid obstructionInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-22-2020 19:31:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/1/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-22-2020 19:31:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003238
Page 122 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.b
Date Location User Value Reason
Sep-22-2020 19:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Arterial hypert
ension
Start Date: Nov/1/2014
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-22-2020 19:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-22-2020 19:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Arterial hypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-22-2020 19:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/1/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-22-2020 19:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003239
Page 123 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Sep-22-2020 19:31:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:Hypercholester
olemia
Start Date: Jul/1/2014
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-22-2020 19:31:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-22-2020 19:31:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HypercholesterolemiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-22-2020 19:31:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jul/1/2014Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-22-2020 19:31:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003240
Page 124 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-22-2020 19:32:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:Stroke
Start Date: Nov/1/2014
Ongoing: NO
End Date:
Nov/1/20
14Initial Entry
1.d Line/MH Number:
Date Location User Value Reason
Sep-22-2020 19:32:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-22-2020 19:32:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
StrokeInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-22-2020 19:32:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/1/2014Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-22-2020 19:32:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
Nov/1/2014Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003241
Page 125 of 250
***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: 44441371 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-22-2020 19:32:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
The subject is NOT known to b
e HIV POSITIVEInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003242
Page 126 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020 19:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-22-2020 19:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
100.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-22-2020 19:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-22-2020 19:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
164.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-22-2020 19:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (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-2021-5683-1003243
Page 127 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-22-2020 19:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
37.2Initial Entry
7.a
Date Location User Value Reason
Sep-22-2020 19:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 36.3
Temperature Un
it:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-22-2020 19:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-22-2020 19:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.3Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-22-2020 19:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-22-2020 19:32:55 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (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-2021-5683-1003244
Page 128 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos AiresORAL CAVITY
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003245
Page 129 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-22-2020 19:33:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-22-2020 19:33:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
263471Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003246
Page 130 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020 19:33:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 19:33:10
(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 14:04:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-23-2020 03:27:21
(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.
Sep-22-2020 19:33:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-22-2020 19:33:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003247
Page 131 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.a
Date Location User Value Reason
Sep-23-2020 14:04:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRVM5MInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-23-2020 14:04:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRVM5MInitial Entry
5.b
Date Location User Value Reason
Sep-23-2020 14:37:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BRVM53Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-23-2020 14:37:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BRVM53Initial Entry
5.c
Date Location User Value Reason
Sep-23-2020 17:19:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHXG6ZInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-23-2020 17:19:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHXG6ZInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003248
Page 132 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020 19:33:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 19:33:16
(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 08:24:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-23-2020 03:27:21
(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.
Sep-22-2020 19:33:16
(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-22-2020 19:33:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003249
Page 133 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.a
Date Location User Value Reason
Sep-23-2020 08:24:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPWBSPInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-23-2020 08:24:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPWBSPInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003250
Page 134 of 250
***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: 44441371 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-22-2020 19:33:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020 19:33:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020 19:33:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-22-2020 19:33:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/22/2020 13:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020 19:33:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003251
Page 135 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-22-2020 19:33:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-22-2020 19:33:30
(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-22-2020 19:33:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-22-2020 19:33:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003252
Page 136 of 250
***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: 44441371 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-22-2020 19:33:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003253
Page 137 of 250
***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: 44441371 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 17:14:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003254
Page 138 of 250
***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: 44441371 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 17:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
2.a
Date Location User Value Reason
Oct-14-2020 17:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.2
Temperature Unit
:C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-14-2020 17:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-14-2020 17:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.2Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003255
Page 139 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-14-2020 17:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-14-2020 17:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003256
Page 140 of 250
***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: 44441371 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 19:14:32
(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 19:14:32
(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 19:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 19:14:32
(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 19:14:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020 19:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BP1VCFInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003257
Page 141 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.a Sample ID
Date Location User Value Reason
Oct-13-2020 19:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BP1VCFInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003258
Page 142 of 250
***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: 44441371 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 17:16:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-14-2020 17:16:37
(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 17:16:37
(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 17:16:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/13/2020 17:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-14-2020 17:16:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003259
Page 143 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-14-2020 17:16:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Oct-14-2020 17:16:37
(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 17:16:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-14-2020 17:16:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003260
Page 144 of 250
***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: 44441371 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 14:54:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/12/2020Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003261
Page 145 of 250
***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: 44441371 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 14:54:59
(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 14:54:59
(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 18:29:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-12-2020 14:54:59
(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 14:54:59
(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 18:29:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BP1PY9Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003262
Page 146 of 250
***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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.a Sample ID
Date Location User Value Reason
Nov-12-2020 18:29:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BP1PY9Initial Entry
5.b
Date Location User Value Reason
Nov-12-2020 18:59:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BNTRB2Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-12-2020 18:59:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BNTRB2Initial Entry
5.c
Date Location User Value Reason
Nov-12-2020 19:08:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BNTR7PInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-12-2020 19:08:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BNTR7PInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003263
Page 147 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021 12:29:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-19-2021 12:24:55
(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.
Jan-19-2021 12:24:55
(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.
Jan-19-2021 12:24:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/17/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-19-2021 12:24:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003264
Page 148 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/17/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/15/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-08-2021 10:45:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolve
d:
Feb/4/2021New Information
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (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-2021-5683-1003265
Page 149 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF BInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003266
Page 150 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
REATH
Sympto
m Prese
nt:NO
4.c Symptoms:
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORT
NESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (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-2021-5683-1003267
Page 151 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.e
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAIN
Symptom
Present:YESInitial Entry
4.e Symptoms:
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms
:NEW LOSS OF TA
STE OR SMELL
Symptom
Present:NOInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003268
Page 152 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.f Symptoms:
Date Location User Value Reason
Jan-19-2021 12:26:52
(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
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (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-2021-5683-1003269
Page 153 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: YESInitial Entry
4.h Symptoms:
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-19-2021 12:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003270
Page 154 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Jan-19-2021 12:27:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms - Other: AstheniaInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Jan-19-2021 12:27:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
AstheniaInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003271
Page 155 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Jan-19-2021 12:27:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003272
Page 156 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Jan-23-2021 19:42:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliForm Created
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003273
Page 157 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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
Jan-19-2021 12:27:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/17/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-19-2021 12:27:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-19-2021 12:27:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Jan-19-2021 12:27:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Jan-19-2021 12:27:56
(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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003274
Page 158 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Jan-19-2021 12:27:56
(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
Jan-19-2021 12:27:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003275
Page 159 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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
Jan-23-2021 19:42:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Jan/20/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-23-2021 19:42:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-23-2021 19:42:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Jan-23-2021 19:42:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Jan-23-2021 19:42:28
(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
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003276
Page 160 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Jan-23-2021 19:42:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Jan-23-2021 19:42:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
POSITIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Jan-23-2021 19:42:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NALT unknownInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003277
Page 161 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021 12:28:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 12:28:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021 12:28:18
(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
Jan-19-2021 12:28:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample collected by a team physi
cianInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003278
Page 162 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021 12:29:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 12:29:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021 15:12:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-19-2021 12:29:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-19-2021 12:29:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/17/2021Initial Entry
5.a
Date Location User Value Reason
Jan-19-2021 15:12:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPWB9NInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003279
Page 163 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.a Sample ID
Date Location User Value Reason
Jan-19-2021 15:12:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPWB9NInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003280
Page 164 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Jan-19-2021 12:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Jan-19-2021 12:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-19-2021 12:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Jan-21-2021 12:38:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practit
ioner:EMERGENCY
ROOM
Occurrence of
Visits or Conta
cts:YES
Number of Vis
its or Contact
s:
1New Information
Jan-19-2021 12:29:25
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Type of Practition EMERGENInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (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-2021-5683-1003281
Page 165 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires er: CY ROOM
Occurrence of Vis
its or Contacts:NO
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Jan-19-2021 12:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-21-2021 12:38:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Contacts:
1New Information
Jan-19-2021 12:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Jan-19-2021 12:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (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-2021-5683-1003282
Page 166 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Jan-19-2021 12:29:25
(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
Jan-19-2021 12:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Jan-19-2021 12:29:25
(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
Jan-19-2021 12:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-19-2021 12:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (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-2021-5683-1003283
Page 167 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Jan-19-2021 12:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Conta
cts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Jan-19-2021 12:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-19-2021 12:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Jan-19-2021 12:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits or
Contacts:NOInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003284
Page 168 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Jan-19-2021 12:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-19-2021 12:29:25
(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
Jan-21-2021 12:38:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Has the subject been in intensiv
e care due to potential COVID-
19 illness?
NONew Information
Jan-19-2021 12:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003285
Page 169 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Jan-21-2021 12:38:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003286
Page 170 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Jan-21-2021 12:38:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Jan-21-2021 12:38:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HOSPITALInitial Entry
3. Admission Date:
Date Location User Value Reason
Jan-21-2021 12:38:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
4. Ongoing?
Date Location User Value Reason
Jan-26-2021 12:36:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
Discharge Date:
Jan/25/2021New Information
Jan-21-2021 12:38:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003287
Page 171 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 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
Jan-19-2021 12:29:36
(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-08-2021
17:15:50
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1: Cl
osedDiscrepancy has
been closed.
Feb-08-2021
14:54:46
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: An
sweredNew
Information
Feb-08-2021
14:54:46
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Respirator
y Illness Di
agnosis:
BILATE
RAL PN
EUMON
IA DUE
TO COV
ID-19 DI
SEASE
Date of Di
agnosis:
Jan/20/20
21New
Information
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003288
Page 172 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-08-2021
12:27:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1: Op
enedClarify
BILATERAL
PNEUMONIA
DUE TO
COVID
DISEASE as
follows...The
term appears
incomplete. Are
you reporting
BILATERAL
PNEUMONIA
DUE TO
COVID-19
DISEASE? If
so, update the
verbatim term
as such.
Otherwise
clarify and edit
the term. Thank
you.
Feb-08-2021
10:48:50
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Respirator
y Illness Di
agnosis:
Bilateral
pneumon
ia due to
Covid dis
ease
Date of Di
agnosis:
Jan/20/20
21New
Information
Jan-23-2021
19:43:08
(UTC-03:00)
City of BuenosACV0PFEINFP6000 Martina Davalli Data Entry:
YES
Respirator
y Illness DiNew
Information
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003289
Page 173 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Aires agnosis:
COVID-
19 Illness
Date of Di
agnosis:
Jan/20/20
21
Jan-22-2021
12:37:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Respirator
y Illness Di
agnosis:
acute bac
terial pne
umonia
Date of Di
agnosis:
Jan/19/20
21New
Information
Jan-19-2021
12:29:36
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Feb-08-2021 10:49:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2New Information
Jan-19-2021 12:29:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1003290
Page 174 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003291
Page 175 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-27-2021 14:05:43
(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
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sanatorio General Sarmiento de S
an Miguel (Av. Pres. Juan Doming
o Peron 1796, Provincia de Bueno
s Aires)Initial Entry
3. Collection Date:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/20/2021Initial Entry
4. Specimen Type:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:329
Test:: C Reactive Prot
ein_PX329Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003292
Page 176 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Result::
Not Done:: NOT DONE
Lab Normal Ra
nge:
5.a Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
329Initial Entry
5.a Test:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
C Reactive Protein_PX329Initial Entry
5.a Not Done:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.b
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:30
Test:: Alanine Aminotr
ansferase_PX30
Result::
Not Done:: NOT DONE
Lab Normal R
ange:Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003293
Page 177 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.b Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30Initial Entry
5.b Test:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Alanine Aminotransferase_PX30Initial Entry
5.b Not Done:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.c
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:28
Test:: Aspartate Aminot
ransferase_PX28
Result::
Not Done:: NOT DONE
Lab Normal R
ange:Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003294
Page 178 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.c Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28Initial Entry
5.c Test:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aspartate Aminotransferase_PX28Initial Entry
5.c Not Done:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.d
Date Location User Value Reason
Jan-28-2021 21:41:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sponsor-Defi
ned Identifier
:35
Test:: Alkaline Phosp
hatase_PX35
Result:: 200
Not Done::New Information
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003295
Page 179 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Lab Normal
Range:Low
60
High
300
Unit
U/L
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:35
Test:: Alkaline Phos
phatase_PX35
Result:: 200
Not Done::
Lab Normal
Range:Low
60
High
300Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003296
Page 180 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.d Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35Initial Entry
5.d Test:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Alkaline Phosphatase_PX35Initial Entry
5.d Result:
Date Location User Value Reason
Jan-28-2021 21:41:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Result is present,
but lab normal
range (Low, high or
Unit) is missing.
Please correct or
confirm.
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
200Initial Entry
5.d LNMT
Date Location User Value Reason
Jan-28-2021 21:41:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Low
60
HighNew Information
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003297
Page 181 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
300
Unit
U/L
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
60
High
300Initial Entry
5.e
Date Location User Value Reason
Jan-28-2021 21:41:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sponsor-Defined I
dentifier:21
Test:: Bilirubin_
PX21
Result:: 0.78
Not Done::
Lab Normal Rang
e:Low
0
High
1
Unit
mg/dLInitial Entry
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:21
Test:: Bilirubin_
PX21
Result:: 0.78
Not Done::
Lab Normal Rang
e:Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003298
Page 182 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.e Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
21Initial Entry
5.e Test:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Bilirubin_PX21Initial Entry
5.e Result:
Date Location User Value Reason
Jan-28-2021 21:41:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Result is present,
but lab normal
range (Low, high or
Unit) is missing.
Please correct or
confirm.
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
0.78Initial Entry
5.e LNMT
Date Location User Value Reason
Jan-28-2021 21:41:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Low
0
HighInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003299
Page 183 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1
Unit
mg/dL
5.f
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:47
Test:: Blood Urea Nitr
ogen_PX47
Result:: 0.38
Not Done::
Lab Normal Ra
nge:Low
unk
High
unk
Unit
g/LInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003300
Page 184 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.f Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
47Initial Entry
5.f Test:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Blood Urea Nitrogen_PX47Initial Entry
5.f Result:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
0.38Initial Entry
5.f LNMT
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
unk
High
unk
Unit
g/LInitial Entry
5.g
Date Location User Value Reason
Jan-28-2021 21:42:37
(UTC-03:00) City ofACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sponsor-Defined 48Transcription Error
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003301
Page 185 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires Identifier:
Test:: Creatinine_
PX48
Result:: 1.31
Not Done::
Lab Normal Ran
ge:Low
0.8
High
1.4
Unit
mg/dL
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:48
Test:: Creatinine_
PX48
Result:: 1.31
Not Done::
Lab Normal Ran
ge:Low
0.8
High
1.4Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003302
Page 186 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.g Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
48Initial Entry
5.g Test:
Date Location User Value Reason
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Creatinine_PX48Initial Entry
5.g Result:
Date Location User Value Reason
Jan-28-2021 21:42:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Result is present,
but lab normal
range (Low, high or
Unit) is missing.
Please correct or
confirm.
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1.31Initial Entry
5.g LNMT
Date Location User Value Reason
Jan-28-2021 21:42:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Low
0.8
HighTranscription Error
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003303
Page 187 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: 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: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.4
Unit
mg/dL
Jan-27-2021 14:05:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
0.8
High
1.4Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1003304
Page 188 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Audit Trail
Form Version: 15-Sep-2020 21:55 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003305
Page 189 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HEMATOLOGYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sanatorio General Sarmiento de S
an Miguel (Av. Pres. Juan Doming
o Peron 1796, Provincia de Bueno
s Aires)Initial Entry
3. Collection Date:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/20/2021Initial Entry
4. Specimen Type:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Jan-28-2021 21:43:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sponsor-Defined
Identifier:1
Test:: Hemoglobi
n_PX1Transcription Error
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003306
Page 190 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Result:: 12,8
Not Done::
Lab Normal Ran
ge:Low
unk
High
unk
Unit
g/dL
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:1
Test:: Hemoglobi
n_PX1
Result:: 12,8
Not Done::
Lab Normal Ran
ge:Low
unk
High
unkInitial Entry
5.a Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
5.a Test:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Hemoglobin_PX1Initial Entry
5.a Result:
Date Location User Value Reason
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003307
Page 191 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Jan-28-2021 21:43:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Result is present,
but lab normal
range (Low, high or
Unit) is missing.
Please correct or
confirm.
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12,8Initial Entry
5.a LNMT
Date Location User Value Reason
Jan-28-2021 21:43:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Low
unk
High
unk
Unit
g/dLTranscription Error
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
unk
High
unkInitial Entry
5.b
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:2Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003308
Page 192 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Test:: Hematocrit_
PX2
Result:: 38
Not Done::
Lab Normal Range
:Low
unk
High
unk
Unit
%
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003309
Page 193 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.b Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
5.b Test:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Hematocrit_PX2Initial Entry
5.b Result:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
38Initial Entry
5.b LNMT
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
unk
High
unk
Unit
%Initial Entry
5.c
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City ofACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Id 3Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003310
Page 194 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires entifier:
Test:: Erythrocytes
_PX3
Result::
Not Done:: NOT DONE
Lab Normal Range
:
5.c Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
5.c Test:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Erythrocytes_PX3Initial Entry
5.c Not Done:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.d
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Ide
ntifier:5
Test:: Platelets_P
X5
Result:: 264000Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003311
Page 195 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Not Done::
Lab Normal Range: Low
unk
High
unk
Unit
10^9/L
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003312
Page 196 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.d Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
5.d Test:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Platelets_PX5Initial Entry
5.d Result:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
264000Initial Entry
5.d LNMT
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
unk
High
unk
Unit
10^9/LInitial Entry
5.e
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City ofACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Id 7Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003313
Page 197 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires entifier:
Test:: Leukocytes_
PX7
Result:: 14900
Not Done::
Lab Normal Range
:Low
unk
High
unk
Unit
10^9/L
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003314
Page 198 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.e Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
5.e Test:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Leukocytes_PX7Initial Entry
5.e Result:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
14900Initial Entry
5.e LNMT
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
unk
High
unk
Unit
10^9/LInitial Entry
5.f
Date Location User Value Reason
Jan-28-2021 21:45:06
(UTC-03:00) City ofACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sponsor-Define 608Transcription Error
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003315
Page 199 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires d Identifier:
Test:: Neutrophils
_PX608
Result:: 10579
Not Done::
Lab Normal Ra
nge:Low
unk
High
unk
Unit
/uL
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:608
Test:: Neutrophils
_PX608
Result:: 10579
Not Done::
Lab Normal Ra
nge:Low
unk
High
unkInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003316
Page 200 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.f Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
608Initial Entry
5.f Test:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Neutrophils_PX608Initial Entry
5.f Result:
Date Location User ValueReason
Jan-29-2021
13:29:13
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
2: Clo
sedClose per site
confirmation
Jan-28-2021
21:46:16
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Santiago Corradetti Query
2: An
swere
dWBC differentials are
indeed entered as
absolute values.
Thank you.
Jan-28-2021
21:45:06
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: Clo
sedClose Auto Query
Jan-28-2021
07:58:17
(UTC-03:00)
City ofACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Op
enedDMW7034229;Please
confirm that the
WBC differentials are
entered as absolute
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003317
Page 201 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos
Airesvalues instead of
percentages, or
correct as
appropriate.
Jan-27-2021
14:14:42
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: Op
enedResult is present, but
lab normal range
(Low, high or Unit) is
missing. Please
correct or confirm.
Jan-27-2021
14:14:42
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
10579Initial Entry
5.f LNMT
Date Location User Value Reason
Jan-28-2021 21:45:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Low
unk
High
unk
Unit
/uLTranscription Error
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
unk
High
unkInitial Entry
5.g
Date Location User Value Reason
Jan-28-2021 21:45:27
(UTC-03:00) City ofACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sponsor-Define 609Transcription Error
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003318
Page 202 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires d Identifier:
Test:: Eosinophils
_PX609
Result:: 0
Not Done::
Lab Normal Ra
nge:Low
unk
High
unk
Unit
/uL
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:609
Test:: Eosinophils
_PX609
Result:: 0
Not Done::
Lab Normal Ra
nge:Low
unk
High
unkInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003319
Page 203 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.g Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
609Initial Entry
5.g Test:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Eosinophils_PX609Initial Entry
5.g Result:
Date Location User Value Reason
Jan-28-2021 21:45:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Result is present,
but lab normal
range (Low, high or
Unit) is missing.
Please correct or
confirm.
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
0Initial Entry
5.g LNMT
Date Location User Value Reason
Jan-28-2021 21:45:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Low
unk
HighTranscription Error
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003320
Page 204 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
unk
Unit
/uL
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
unk
High
unkInitial Entry
5.h
Date Location User Value Reason
Jan-28-2021 21:45:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sponsor-Defined
Identifier:612
Test:: Monocytes_
PX612
Result:: 1490
Not Done::
Lab Normal Ra
nge:Low
unk
High
unk
Unit
/uLTranscription Error
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003321
Page 205 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
5.h
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:612
Test:: Monocytes_
PX612
Result:: 1490
Not Done::
Lab Normal Rang
e:Low
unk
High
unkInitial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003322
Page 206 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.h Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
612Initial Entry
5.h Test:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Monocytes_PX612Initial Entry
5.h Result:
Date Location User Value Reason
Jan-28-2021 21:45:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Result is present,
but lab normal
range (Low, high or
Unit) is missing.
Please correct or
confirm.
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1490Initial Entry
5.h LNMT
Date Location User Value Reason
Jan-28-2021 21:45:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Low
unk
HighTranscription Error
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003323
Page 207 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
unk
Unit
/uL
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
unk
High
unkInitial Entry
5.i
Date Location User Value Reason
Jan-28-2021 21:46:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sponsor-Defined
Identifier:610
Test:: Basophils_
PX610
Result:: 0
Not Done::
Lab Normal Ra
nge:Low
unk
High
unk
Unit
/uLTranscription Error
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:610
Test:: Basophils_
PX610
Result:: 0
Not Done::Initial Entry
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1003324
Page 208 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Lab Normal Ra
nge:Low
unk
High
unk
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-1003325
Page 209 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.i Sponsor ID:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
610Initial Entry
5.i Test:
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Basophils_PX610Initial Entry
5.i Result:
Date Location User Value Reason
Jan-28-2021 21:46:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Result is present,
but lab normal
range (Low, high or
Unit) is missing.
Please correct or
confirm.
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
0Initial Entry
5.i LNMT
Date Location User Value Reason
Jan-28-2021 21:46:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Low
unk
HighTranscription Error
090177e196ae2ecc\Final\Final On: 01-Apr-2021 03:23 (GMT)
(b) (4)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-1003326
Page 210 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/17/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441371 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
unk
Unit
/uL
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
unk
High
unkInitial Entry
5.j
Date Location User Value Reason
Jan-27-2021 14:14:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP60
…[truncated]