Document text
Page 1 of 214
***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: 44442304 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
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006885
Page 2 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/27/2020
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006886
Page 3 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Demography
1.Subject ID [44442304]
2.Birth Date: /1971
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006887
Page 4 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/27/2020
2.Erroneous Visit
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006888
Page 5 of 214
***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: 44442304 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
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006889
Page 6 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006890
Page 7 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: Nov/1/2019
Ongoing: YES
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006891
Page 8 of 214
***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: 44442304 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
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006892
Page 9 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Sep/27/2020
2.Weight: [94.0]
3.Unit: kg
4.Height: [169.0]
5.Unit: cm
6.Body Mass Index: [32.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006893
Page 10 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/27/2020
2.Randomization Number: [101104]
3.Randomization Group: [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006894
Page 11 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/27/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRVFMD]
5.bSample ID [BPXJN5]
5.cSample ID [BRVFLM]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006895
Page 12 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/27/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1V2X]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006896
Page 13 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/27/2020 17:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006897
Page 14 of 214
***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: 44442304 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
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006898
Page 15 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006899
Page 16 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Oct/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006900
Page 17 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BKNZJP]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006901
Page 18 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/15/2020 14:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006902
Page 19 of 214
***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: 44442304 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
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006903
Page 20 of 214
***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: 44442304 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 [BNTRBM]
5.bSample ID [BP1PWR]
5.cSample ID [BNTR95]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006904
Page 21 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: 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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006905
Page 22 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/27/2020
2.Date of First Symptom Started: Oct/26/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/11/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006906
Page 23 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [asthenia]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006907
Page 24 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date of
Collectio
nSpecimen T
ypeSpecimen Col
lection Locati
onAssay Code and Descripti
onDevice TypeForm Insta
nce
1.Oct/27/2
020 SWABBED
MATERIA
L NASOPHARY
NX SEVERE ACUTE RESP S
YNDROME CORONAVIR
US 2 SARS-COV-2 D
IAGNOSTIC TE
ST Repeating
Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006908
Page 25 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 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: Oct/27/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006909
Page 26 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: 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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[sample collected by team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006910
Page 27 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: 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: 44442304 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/27/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPT7ZW]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006911
Page 28 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 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:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006912
Page 29 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006913
Page 30 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Treatment Ident
ifierCon Non-Drug Treatments Pre-
specifiedTreatme
ntTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006914
Page 31 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: 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: 44442304 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?
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006915
Page 32 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 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:
[COVID-19 illness]
Date of Diagnosis:
Oct/27/2020
3.Toxicity Grade: 1
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006916
Page 33 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category of Clinical E
vent:Subcategory of Clinical
EventDiagnosis Obtai
nedToxicity Gra
deForm Instance
1. Repeating
Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006917
Page 34 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: 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: 44442304 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:
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006918
Page 35 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category for
Lab TestVendor
NameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006919
Page 36 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006920
Page 37 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1. Sponsor-Define
d IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006921
Page 38 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006922
Page 39 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Date: Vital Signs Details Form Instance
1. DELETED Record Identifier: Systolic: Diastolic:
1 Repeating Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006923
Page 40 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Date: Vital Signs Details Form Instance
2.Oct/27/2020 Record Identifier: Systolic: Diastolic:
1 140 80 Repeating Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006924
Page 41 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Incomplete, Data Complete, Deleted, Frozen,
Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: //
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006925
Page 42 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 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: Oct/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [140]
Diastolic: [80]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [125]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006926
Page 43 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006927
Page 44 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006928
Page 45 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date Time of Assessm
entArterial Blood Gases Pa
O2FiO2 (Fraction of Inhaled Oxy
gen)Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating
Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006929
Page 46 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006930
Page 47 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006931
Page 48 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: 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: 44442304 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?
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006932
Page 49 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date of Assessme
ntLocation of Assessme
ntImaging Metho
dOverall Assessme
ntForm Instance
1. Repeating Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006933
Page 50 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006934
Page 51 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/25/2020Form: 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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/25/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006935
Page 52 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/25/2020Form: 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: 44442304 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/25/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRVMGF]
5.bSample ID [BPWSPM]
5.cSample ID [BRVMGP]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006936
Page 53 of 214
***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: 44442304 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:
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006937
Page 54 of 214
***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: 44442304 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 [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006938
Page 55 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006939
Page 56 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Unplanned Assessments
1.Assessments
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006940
Page 57 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#CategoryAE Identi
fierAdverse E
ventStart DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 hyperglyce
mia Oct/29/2020 1
2:00 YES Repeating
Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006941
Page 58 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 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)[hyperglycemia]
4.Start Date Time: Oct/29/2020 12:00
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006942
Page 59 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006943
Page 60 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categ
oryMedication
ErrorStart D
ateIs the medication error St
ill OngoingStudy Medication Err
ors ActionForm Instanc
e
1. Repeating
Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006944
Page 61 of 214
***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: 44442304 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[ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006945
Page 62 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006946
Page 63 of 214
***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: 44442304 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: //
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006947
Page 64 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006948
Page 65 of 214
***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: 44442304 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?
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006949
Page 66 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006950
Page 67 of 214
***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: 44442304 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?
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006951
Page 68 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006952
Page 69 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006953
Page 70 of 214
***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: 44442304 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: [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006954
Page 71 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006955
Page 72 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 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:
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006956
Page 73 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 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?
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006957
Page 74 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006958
Page 75 of 214
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006959
Page 76 of 214
***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: 44442304 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: [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006960
Page 77 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006961
Page 78 of 214
***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: 44442304 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
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006962
Page 79 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/24/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006963
Page 80 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006964
Page 81 of 214
***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: 44442304 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: [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006965
Page 82 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006966
Page 83 of 214
***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: 44442304 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/25/2021
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006967
Page 84 of 214
***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: 44442304 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
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006968
Page 85 of 214
***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: 44442304 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/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006969
Page 86 of 214
***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: 44442304 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/25/2021
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 [BRZ1DL]
5.bSample ID [BRZ1FH]
5.cSample ID [BR1ZRV]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006970
Page 87 of 214
***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: 44442304 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/25/2021
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 [BR21BC]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006971
Page 88 of 214
***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: 44442304 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/25/2021 14:22
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006972
Page 89 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006973
Page 90 of 214
***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: 44442304 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 [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006974
Page 91 of 214
***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: 44442304 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?
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006975
Page 92 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006976
Page 93 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006977
Page 94 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006978
Page 95 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006979
Page 96 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006980
Page 97 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006981
Page 98 of 214
***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: 44442304 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: [ ]
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006982
Page 99 of 214
***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: 44442304 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
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006983
Page 100 of 214
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 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
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006984
Page 101 of 214
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Yanina
Rivera Approved Mar-10-2021 23:04:42 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, YaninaRivera, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006985
Page 102 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-28-2020 10:46:18 (UTC-03:00) City
of Buenos AiresNot Applicable
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006986
Page 103 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormNov-13-2020 08:58:39 (UTC-03:00) City
of Buenos Aires
FormSep-28-2020 10:46:40 (UTC-03:00) City
of Buenos AiresNot Applicable
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006987
Page 104 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Incomplete, Data Complete, Deleted, Frozen,
Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormOct-30-2020 18:48:21 (UTC-03:00) City
of Buenos AiresBlood pressure: 140/80
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006988
Page 105 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormNov-19-2020 17:23:59 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006989
Page 106 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
1Nov-19-2020 17:23:59 (UTC-03:00) City
of Buenos AiresNot Applicable
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006990
Page 107 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
2Nov-19-2020 17:23:59 (UTC-03:00) City
of Buenos AiresNot Applicable
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006991
Page 108 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
3Nov-19-2020 17:23:59 (UTC-03:00) City
of Buenos AiresNot Applicable
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006992
Page 109 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormFeb-25-2021 17:41:27 (UTC-03:00) City
of Buenos AiresNot Applicable
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006993
Page 110 of 214
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Yanina
Rivera Approved Mar-10-2021 23:04:42 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, YaninaRivera, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-24-2021 12:34:06 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-27-2020 19:20:27 (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.
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006994
Page 111 of 214
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
N/A Nov-26-2020 09:22:31 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-25-2020 18:54:24 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-25-2020 13:34:45 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Nov-24-2020 09:51:33 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006995
Page 112 of 214
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
N/A Nov-19-2020 17:23:59 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-13-2020 18:30:30 (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 08:58:39 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-12-2020 19:12:41 (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.
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006996
Page 113 of 214
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
N/A Nov-12-2020 13:57:21 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-12-2020 09:30:31 (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 09:18:12 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-11-2020 18:51:14 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006997
Page 114 of 214
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
N/A Nov-11-2020 09:32:26 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-10-2020 11:49:16 (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-04-2020 19:36:10 (UTC-03:00) City
of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-31-2020 13:21:16 (UTC-03:00) City
of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006998
Page 115 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-28-2020
10:45:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-28-2020
10:45:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006999
Page 116 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-28-2020
10:45:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Ob
tained
Sep/27/2020Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007000
Page 117 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-27-2020 17:40:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
44442304Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-27-2020
17:40:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1971Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-28-2020
10:46:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-28-2020
10:46:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(
A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007001
Page 118 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-28-2020
10:46:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007002
Page 119 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-28-2020
10:46:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/27/2020Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007003
Page 120 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-28-2020
10:46:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-28-2020 10:46:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-28-2020
10:46:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007004
Page 121 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Nov-13-2020
08:59:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Obesity
Start Date: Nov/1/2
019
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Nov-13-2020
08:59:04
(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
Nov-13-2020
08:59:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ObesityInitial Entry
1.a Start Date:
Date Location User Value Reason
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007005
Page 122 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nov-13-2020
08:59:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/1/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Nov-13-2020
08:59:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007006
Page 123 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-28-2020
10:46:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
The subject is NOT known
to be HIV POSITIVEInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007007
Page 124 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Sep-28-2020
10:47:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-28-2020
10:47:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
94.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-28-2020
10:47:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-28-2020
10:47:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
169.0Initial Entry
5. Unit:
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007008
Page 125 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Sep-28-2020
10:47:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-28-2020 10:47:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
32.9Initial Entry
7.a
Date Location User Value Reason
Sep-28-2020
10:47:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identif
ier::1
Temperature: 36.6
Temperature
Unit:C
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-28-2020
10:47:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007009
Page 126 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Sep-28-2020
10:47:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-28-2020
10:47:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-28-2020
10:47:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007010
Page 127 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-28-2020
10:47:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-28-2020
10:47:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
101104Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007011
Page 128 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 10:47:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 10:47:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020
11:31:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-28-2020
10:47:23
(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-28-2020
10:47:23
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007012
Page 129 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires
Sep/27/2020
5.a
Date Location User Value Reason
Sep-28-2020
11:31:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRVFMDInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-28-2020
11:31:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRVFMDInitial Entry
5.b
Date Location User Value Reason
Sep-29-2020
08:49:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPXJN5Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-29-2020
08:49:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPXJN5Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007013
Page 130 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.c
Date Location User Value Reason
Sep-29-2020
08:51:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BRVFLMInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-29-2020
08:51:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BRVFLMInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007014
Page 131 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 10:47:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 10:47:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020
08:03:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-29-2020
05:49:08
(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-28-2020
10:47:30
(UTC-03:00) City ofACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1007015
Page 132 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires barcodes are
entered. Please
review and
correct as
appropriate.
Sep-28-2020
10:47:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/27/2020Initial Entry
5.a
Date Location User Value Reason
Sep-29-2020
08:03:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP1V2XInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020
08:03:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP1V2XInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007016
Page 133 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-28-2020
10:47:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020 10:47:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020 10:47:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-28-2020
10:47:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/27/2020 17:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007017
Page 134 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-28-2020 10:47:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-28-2020
10:47:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-28-2020 10:47:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-28-2020 10:47:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-28-2020
10:47:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007018
Page 135 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-28-2020
10:47:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLEC
TED FOR THIS SUBJEC
TInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007019
Page 136 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020
03:18:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed As per site
confirmation -
updated PD
tracker
Oct-16-2020
14:56:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Original value is
correct.
According to the
protocol. The
subject is not out
of window (19
days since visit
1).
Oct-16-2020
09:19:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Sandip
Namdeorao
SuryawanshiQuery 1: Opened PDQ: DOV at
this visit is out of
window (-1 day)
from DOV
(27/Sep/2020) at
V1D1VX1L.
Please reconcile
and update
accordingly, else
confirm date is
correct as is.
Oct-15-2020
17:29:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007020
Page 137 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Oct-15-2020
17:29:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
2.a
Date Location User Value Reason
Oct-15-2020
17:29:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identif
ier::1
Temperature: 36.4
Temperature
Unit:C
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-15-2020
17:29:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-15-2020
17:29:27ACV0PFEINFP6000 Data Entry:
36.4Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007021
Page 138 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos Aires
2.a Unit:
Date Location User Value Reason
Oct-15-2020
17:29:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-15-2020
17:29:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007022
Page 139 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 17:29:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 17:29:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
18:42:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-15-2020
17:29:42
(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-15-2020
17:29:42
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007023
Page 140 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires
Oct/15/2020
5.a
Date Location User Value Reason
Oct-15-2020
18:42:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BKNZJPInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020
18:42:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BKNZJPInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007024
Page 141 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-15-2020
17:30:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-15-2020 17:30:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-15-2020 17:30:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-15-2020
17:30:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/15/2020 14:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007025
Page 142 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-15-2020 17:30:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-15-2020
17:30:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-15-2020 17:30:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-15-2020 17:30:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Oct-15-2020
17:30:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007026
Page 143 of 214
***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: 44442304 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
13:57:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/12/2020Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007027
Page 144 of 214
***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: 44442304 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
13:57:38
(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
13:57:38
(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
16:39:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-12-2020
13:57:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Nov-12-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1007028
Page 145 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
13:57:38
(UTC-03:00) City of
Buenos AiresYES
Date of Collection:
Nov/12/2020
5.a
Date Location User Value Reason
Nov-12-2020
16:39:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BNTRBMInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-12-2020
16:39:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BNTRBMInitial Entry
5.b
Date Location User Value Reason
Nov-12-2020
18:39:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BP1PWRInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007029
Page 146 of 214
***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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.b Sample ID
Date Location User Value Reason
Nov-12-2020
18:39:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BP1PWRInitial Entry
5.c
Date Location User Value Reason
Nov-12-2020
18:49:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BNTR95Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-12-2020
18:49:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BNTR95Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007030
Page 147 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 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-28-2020
18:22:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Oct-28-2020
18:18:53
(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.
Oct-28-2020
18:18:53
(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.
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1007031
Page 148 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-28-2020
18:18:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-28-2020 18:18:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007032
Page 149 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/26/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Nov-12-2020
09:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom R
esolved:
Nov/11/2020New Information
Nov-11-2020
09:32:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom R
esolved:
Nov/8/2020New Information
Oct-28-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (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-2021-5683-1007033
Page 150 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
18:20:48
(UTC-03:00) City of
Buenos AiresYES
4.a
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: FEVE
R
Symptom Present
:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCR
EASED COUGInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (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-2021-5683-1007034
Page 151 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires H
Sympto
m Presen
t:NO
4.b Symptoms:
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED C
OUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR INCRE
ASED SHORTNE
SS OF BREATH
Sympt
om Pre
sent:NOInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007035
Page 152 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.c Symptoms:
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED S
HORTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: CHILL
S
Symptom Presen
t:NOInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007036
Page 153 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.d Symptoms:
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCR
EASED MUSCL
E PAIN
Sympto
m Prese
nt:YESInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007037
Page 154 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.e Symptoms:
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED M
USCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Nov-04-2020
19:55:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW LOSS OF
TASTE OR SM
ELL
Sympto
m Prese
nt:YESNew Information
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW LOSS OF
TASTE OR SM
ELL
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007038
Page 155 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.f Symptoms:
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE O
R SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-04-2020
19:55:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESNew Information
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCR
EASED SORE T
HROAT
Sympto
m Prese
nt:YESInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007039
Page 156 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.g Symptoms:
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED S
ORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: DIARRH
EA
Symptom Pres
ent:NOInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007040
Page 157 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.h Symptoms:
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: VOMITI
NG
Symptom Pres
ent:NOInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007041
Page 158 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.i Symptoms:
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-28-2020
18:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Oct-28-2020
18:21:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms - Othe
r:astheni
aInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Oct-28-2020
18:21:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
astheniaInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007042
Page 159 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: 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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Oct-28-2020 18:22:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007043
Page 160 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 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
Oct-28-2020
18:22:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-28-2020
18:22:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-28-2020
18:22:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-28-2020 18:22:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SY
NDROME CORONAVIRU
S 2Initial Entry
5. Device Type:
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007044
Page 161 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Oct-28-2020 18:22:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTI
C TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Oct-28-2020
18:22:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ATILA BIOSYSTEMS IA
MP COVID-19 DETECTI
ON KITInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-28-2020
18:22:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
POSITIVEInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007045
Page 162 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020 18:22:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020 18:22:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020
18:22:22
(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
Oct-28-2020
18:22:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
sample collected by team p
hysicianInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007046
Page 163 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020 18:22:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020 18:22:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020
08:09:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-28-2020
18:22:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-28-2020
18:22:34
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007047
Page 164 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires
Oct/27/2020
5.a
Date Location User Value Reason
Oct-29-2020
08:09:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPT7ZWInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-29-2020
08:09:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPT7ZWInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007048
Page 165 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:SPECI
ALIST
Occurrence of Vi
sits or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practi
tioner:EMERGE
NCY RO
OMInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007049
Page 166 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Occurrence of
Visits or Cont
acts:NO
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Pra
ctitioner:PRIMARY
CARE PHY
SICIAN
Occurrence
of Visits or
Contacts:NOInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007050
Page 167 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSI
CIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:URGEN
T CARE
Occurrence of
Visits or Contac
ts:NOInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007051
Page 168 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Pra
ctitioner:TELEPHO
NE CONSU
LTATION
Occurrence
of Visits or
Contacts:NOInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007052
Page 169 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULT
ATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitione
r:OTH
ER
Occurrence of Visi
ts or Contacts:NOInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007053
Page 170 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Other Type of Practitioner Specify:
Date Location User Value Reason
Nov-01-2020
01:41:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-31-2020
11:52:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Form updated
Oct-30-2020
19:28:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Open
edCRA: Please
remind
completing this
page once
documented in
Medical chart.
Thanks.
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (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-2021-5683-1007054
Page 171 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-30-2020
16:31:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Pending
information
about potential
covid disease
will be updated
soon
Oct-30-2020
12:56:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Item incomplete
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Oct-31-2020
11:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007055
Page 172 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 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
Nov-01-2020
01:40:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-31-2020
11:51:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Form updated
Oct-30-2020
19:28:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Open
edCRA: Please
remind
completing this
page once
documented in
Medical chart.
Thanks.
Oct-30-2020
18:46:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-1
9 ILLNESSInitial Entry
Oct-30-2020
16:32:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Pending
information
about potential
covid disease
will be updated
soon
Oct-30-2020
12:56:47
(UTC-03:00) City ofACV0PFEINFP6000 Query 1: Opened Item incomplete
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (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-2021-5683-1007056
Page 173 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User ValueReason
Oct-31-2020
12:20:53
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy
has been
closed.
Oct-31-2020
11:51:12
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dNew
Information
Oct-31-2020
11:51:12
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
YES
Res
pira
tory
Illne
ss D
iagn
osis:
C
O
VI
D-
19
ill
neNew
Information
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007057
Page 174 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
ss
Date
of D
iagn
osis:
Oc
t/2
7/2
02
0
Oct-31-2020
07:11:18
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedSpecial
Characters:
Verbatim
Term contains
embedded
non-compliant
characters.
Oct-30-2020
18:46:37
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
YES
Res
pira
tory
Illne
ss D
iagn
osis:
ne
w
or
inc
rea
seInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007058
Page 175 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
d
mu
scl
e p
ain
, o
dy
no
ph
agi
a a
nd
ast
he
nia
ne
w
or
inc
rea
se
d
Date
of D
iagn
osis:
Oc
t/2
7/2
02
0
3. Toxicity Grade:
Date Location User Value Reason
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1007059
Page 176 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-30-2020
18:46:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007060
Page 177 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: VITAL SIGNS - COVID - Audit Trail
Form Version: 15-Sep-2020 21:52 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Oct-30-2020
17:08:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Deleted Transcription
Error
Oct-30-2020
16:21:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007061
Page 178 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: VITAL SIGNS - COVID - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Incomplete, Data Complete, Deleted, Frozen,
Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Date:
Date Location User Value Reason
Nov-04-2020
10:22:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Information is
already captured.
Oct-30-2020
19:26:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Cand
idateCRA: As per
medical chart
documented in
RedCap, heart
rate was 125,
therefore this
page should be
completed.
Please complete.
Thanks.
Oct-30-2020
17:07:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription
Error
Oct-30-2020
16:21:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Oct-30-2020
16:21:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007062
Page 179 of 214
***Confidential***
Oct-30-2020
12:54:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CRA: As hearth
rate was 125,
please complete
this page.
Thanks.
2.a
Date Location User Value Reason
Oct-30-2020
17:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Systolic::
Diastolic::
Respiratory Rate in
respirations/minute:
Heart Rate in beats/
minute:Transcription
Error
Oct-30-2020
16:21:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Systolic:: 1
4
0
Diastolic:: 8
0
Respiratory Rate i
n respirations/min
ute:2
0
Heart Rate in beats
/minute:1
2
5Initial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-30-2020
16:21:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Systolic:
Date Location User Value Reason
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-1007063
Page 180 of 214
***Confidential***
Oct-30-2020
17:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry: Transcription
Error
Oct-30-2020
16:21:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
140Initial Entry
2.a Diastolic:
Date Location User Value Reason
Oct-30-2020
17:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry: Transcription
Error
Oct-30-2020
16:21:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
80Initial Entry
2.a Respiratory Rate in respirations/minute:
Date Location User Value Reason
Oct-30-2020
17:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry: Transcription
Error
Oct-30-2020
16:21:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
20Initial Entry
2.a Heart Rate in beats/minute:
Date Location User Value Reason
Nov-02-2020
07:46:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Closed Data removed
Oct-31-2020
08:33:55
(UTC-03:00) CityACV0PFEINFP6000 Query 1: Reissued:Can
didateData removed
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (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),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1007064
Page 181 of 214
***Confidential***
of Buenos Aires
Oct-30-2020
17:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry: Transcription
Error
Oct-30-2020
17:07:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Answered For the subject
in question, due
to an involuntary
error, vital signs
were loaded that
did not
correspond. We
proceed to delete
them. Thank you
Oct-30-2020
16:21:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Heart rate 125 is
outside of
Normal Range 0
- 120.
Oct-30-2020
16:21:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
125Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-1007065
Page 182 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: VITAL SIGNS - COVID - Audit Trail
Form Version: 10-Oct-2020 15:59 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Oct-31-2020
12:33:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Form Created
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007066
Page 183 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: VITAL SIGNS - COVID - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Oct-31-2020
12:33:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Oct/27/2020Initial Entry
2.a
Date Location User Value Reason
Oct-31-2020
12:33:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
Record Identifier:: 1
Systolic:: 1
4
0
Diastolic:: 8
0
Respiratory Rate in
respirations/minute:2
0
Heart Rate in beats/
minute:1
2
5Initial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-31-2020
12:33:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
1Initial Entry
2.a Systolic:
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007067
Page 184 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: VITAL SIGNS - COVID - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Oct-31-2020
12:33:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
140Initial Entry
2.a Diastolic:
Date Location User Value Reason
Oct-31-2020
12:33:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
80Initial Entry
2.a Respiratory Rate in respirations/minute:
Date Location User Value Reason
Oct-31-2020
12:33:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
20Initial Entry
2.a Heart Rate in beats/minute:
Date Location User Value Reason
Nov-01-2020
01:40:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-31-2020
12:35:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Query 1: Answered Correct, the
information is
correct
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007068
Page 185 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: VITAL SIGNS - COVID - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-31-2020
12:33:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Heart rate 125 is
outside of
Normal Range 0
- 120.
Oct-31-2020
12:33:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
125Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007069
Page 186 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: OXYGENATION PARAMETERS - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date Time of Assessment:
Date Location User Value Reason
Nov-20-2020
01:15:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 1: Closed Response
satisfies query
Nov-19-2020
17:23:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-19-2020
17:23:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Answered subject did not
present any
clinical signs of
severe systemic
illness. this
form is not
applicable to
the subject.
thank you
Nov-19-2020
14:52:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 1: Opened Clin: Please
review if data
are available
and update if
appropriate
2. Arterial Blood Gases PaO2 (mmHg):
Date Location User Value Reason
Nov-19-2020
17:23:59
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007070
Page 187 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/27/2020Form: OXYGENATION PARAMETERS - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires
3. FiO2 (Fraction of Inhaled Oxygen):
Date Location User Value Reason
Nov-19-2020
17:23:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007071
Page 188 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/25/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 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-25-2020
13:34:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/25/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-25-2020
13:34:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007072
Page 189 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/25/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-25-2020
13:34:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-25-2020
13:34:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-26-2020
09:22:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-26-2020
03:47:02
(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.
Nov-25-2020 ACV0PFEINFP6000 auto query Query 1: Candidate 'Sample
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007073
Page 190 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/25/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
13:34:54
(UTC-03:00) City of
Buenos Aires(autoquery) Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Nov-25-2020
13:34:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/25/2020Initial Entry
5.a
Date Location User Value Reason
Nov-26-2020
09:22:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRVMGFInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-26-2020
09:22:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRVMGFInitial Entry
5.b
Date Location User Value Reason
Nov-26-2020
09:22:50
(UTC-03:00) City ofACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Sample ID: BPWSPMInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007074
Page 191 of 214
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/25/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires
5.b Sample ID
Date Location User Value Reason
Nov-26-2020
09:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
BPWSPMInitial Entry
5.c
Date Location User Value Reason
Nov-26-2020
09:31:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRVMGPInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-26-2020
09:31:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRVMGPInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007075
Page 192 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Nov-04-2020 19:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007076
Page 193 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Nov-04-2020
19:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-04-2020
19:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-06-2020
16:12:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Samuel
DychterQuery 1: Closed Response satisfies
query
Nov-06-2020
12:56:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The volunteer
denies a personal
history of
hyperglycemia
and refers to a
family history of
diabetes. Thank
you
Nov-05-2020 ACV0PFEINFP6000 Samuel Query 1: Opened GPD Clin: Per
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007077
Page 194 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
23:13:49
(UTC-03:00) City of
Buenos AiresDychter medical history
there is no
evidence of DM
or pre-diabetes.
Did the subject
have a histx of
hyperglycemia at
baseline? What
was the subject's
glycemia for this
AE?
Nov-04-2020
19:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
hyperglycemiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-04-2020
19:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/29/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-26-2020
14:21:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-25-2020
11:07:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiQuery 1: Answered Yes, the AE is
still ongoing.
The patient is
currently being
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007078
Page 195 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
treated with
NPH Insulin.
Nov-25-2020
10:33:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened GPD Clinical:
please clarify
whether this
Adverse Event
is still Ongoing,
thank you.
Nov-04-2020
19:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-04-2020
19:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-04-2020
19:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007079
Page 196 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-04-2020
19:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-04-2020
19:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is du
e to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-04-2020
19:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007080
Page 197 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nov-04-2020
19:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-04-2020
19:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-04-2020
19:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT
RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-04-2020
19:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007081
Page 198 of 214
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-12-2020
13:57:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-12-2020
13:57:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-12-2020
13:57:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007082
Page 199 of 214
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021
12:34:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/24/2021Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007083
Page 200 of 214
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-24-2021
12:34:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing to retu
rn for Vaccination 3
Participant is:
eligible per other protoc
ol allowance(s) and conf
irmed to have received o
nly placebo at Vaccinati
on 1/2Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007084
Page 201 of 214
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-24-2021
12:34:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/24/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-24-2021
12:34:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FO
R ADDITIONAL VACCIN
ATIONInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007085
Page 202 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021
17:41:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/25/2021Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007086
Page 203 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION -
eCRF Audit Trail History
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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-25-2021
17:41:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obt
ained
Feb/25/2021Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007087
Page 204 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
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: 44442304 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
Feb-25-2021
17:41:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/25/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-25-2021 17:41:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-25-2021
17:41:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007088
Page 205 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-25-2021 17:42:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-25-2021 17:42:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021
09:49:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-26-2021
07:59:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Feb-25-2021
17:42:08
(UTC-03:00) City ofACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007089
Page 206 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires barcodes are
entered. Please
review and
correct as
appropriate.
Feb-25-2021
17:42:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021
09:49:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRZ1DLInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-26-2021
09:49:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRZ1DLInitial Entry
5.b
Date Location User Value Reason
Feb-26-2021
10:16:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRZ1FHInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1007090
Page 207 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.b Sample ID
Date Location User Value Reason
Feb-26-2021
10:16:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRZ1FHInitial Entry
5.c
Date Location User Value Reason
Feb-26-2021
11:51:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BR1ZRVInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-26-2021
11:51:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR1ZRVInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1007091
Page 208 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: 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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-25-2021 17:42:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-25-2021 17:42:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021
11:23:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-26-2021
07:59:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Feb-25-2021
17:42:21
(UTC-03:00) City ofACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1007092
Page 209 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: 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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires barcodes are
entered. Please
review and
correct as
appropriate.
Feb-25-2021
17:42:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021
11:23:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BR21BCInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-26-2021
11:23:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BR21BCInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007093
Page 210 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
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: 44442304 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
Feb-25-2021
17:42:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-25-2021 17:42:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-25-2021 17:42:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-25-2021
17:42:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/25/2021 14:22Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007094
Page 211 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-25-2021 17:42:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-25-2021
17:42:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-25-2021 17:42:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-25-2021 17:42:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-25-2021 17:42:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007095
Page 212 of 214
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
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: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-25-2021 17:42:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Feb-25-2021
17:42:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1007096
Page 213 of 214
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-12-2020
13:57:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-28-2020 10:47:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZE
DInitial Entry
Sep-28-2020 10:46:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-12-2020
13:57:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/12/2020Initial Entry
Sep-28-2020 10:47:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/27/2020Initial Entry
Sep-28-2020 10:46:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/27/2020Initial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-1007097
Page 214 of 214
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr
Cosme Argerich
Subject No: 44442304 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-31-2020
13:21:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Fernando
PolackData Entry:
Click Here to EnableInitial Entry
090177e196ae2efe\Final\Final On: 01-Apr-2021 03:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1007098