Document text
Page 1 of 323
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891020
Page 2 of 323
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/31/2020
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891021
Page 3 of 323
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Demography
1.Subject ID [12315632]
2.Birth Date: 1954
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0891022
Page 4 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891023
Page 5 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891024
Page 6 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891025
Page 7 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891026
Page 8 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [78.5]
3.Unit: kg
4.Height: [174.0]
5.Unit: cm
6.Body Mass Index: [25.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891027
Page 9 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [247322]
3.Randomization Group: [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891028
Page 10 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BP264N]
5.bSample ID [BP264P]
5.cSample ID [BP264R]
5.dSample ID [BNTWWS]
5.eSample ID [BNTWWT]
5 fSample ID [BNTWWV]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891029
Page 11 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BP25RC]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891030
Page 12 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/31/2020 16:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891031
Page 13 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891032
Page 14 of 323
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/19/2020
2.Erroneous Visit
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891033
Page 15 of 323
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Sep/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891034
Page 16 of 323
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/19/2020
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 [BPWF1M]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891035
Page 17 of 323
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/19/2020 14:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891036
Page 18 of 323
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/29/2020 Comments
2.Erroneous Visit Comments
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891037
Page 19 of 323
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type SERUM Comments
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Sample is captured in the convalescent visit wich was carried out the same
day]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891038
Page 20 of 323
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891039
Page 21 of 323
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891040
Page 22 of 323
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891041
Page 23 of 323
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891042
Page 24 of 323
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891043
Page 25 of 323
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891044
Page 26 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891045
Page 27 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/20/2020
2.Date of First Symptom Started: Oct/17/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/7/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891046
Page 28 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.Symptoms - Other Text: [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891047
Page 29 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date of Co
llectionSpecimen TypeSpecimen Collect
ion LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/19/202
0 RESPIRATORY S
ECRETIONS NASOPHARYNX
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
2.Oct/20/202
0 SWABBED MATE
RIAL NASOPHARYNX
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
3.Oct/28/202
0 SWABBED MATE
RIAL NASOPHARYNX
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
4.Nov/30/20
20 SWABBED MATE
RIAL NASOPHARYNX
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891048
Page 30 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/19/2020
2.Specimen Type: RESPIRATORY SECRETIONS
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER Comments
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891049
Page 31 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/20/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891050
Page 32 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/28/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891051
Page 33 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/30/2020
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: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [Unknown]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891052
Page 34 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Sample collected by a team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891053
Page 35 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BPT7WN]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891054
Page 36 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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: YES
Number of Visits or Contacts:
[1]
Health Care Utilization Other
2.Other Type of Practitioner Specify: [home emergency service]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891055
Page 37 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Oct/18/2020 NO
Discharge Date:
Oct/20/2020
Repeating Pages
2.HOSPITALIZATION STATUS HOSPITAL Nov/18/2020 NO
Discharge Date:
Dec/5/2020
Repeating Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891056
Page 38 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Oct/18/2020
4.Ongoing? NO
Discharge Date:
Oct/20/2020
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891057
Page 39 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Nov/18/2020
4.Ongoing? NO
Discharge Date:
Dec/5/2020
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891058
Page 40 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891059
Page 41 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891060
Page 42 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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:
[Pericarditis]
Date of Diagnosis:
Nov/24/2020
3.Toxicity Grade: 4
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891061
Page 43 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891062
Page 44 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891063
Page 45 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category for
Lab TestVendor NameCollecti
on Date:Specim
en TypeLab ResultForm Instan
ce
1.CLINICAL C
HEMISTRY Ramos Mejia Hospital. General
Urquiza 609, Buenos Aires city
Dec/5/20
20 BLOOD
Sponsor-Defi
ned Identifie
rTest:Res
ult:
329 C Reactive Protei
n_PX329 33
30 Alanine Aminotr
ansferase_PX30 24
28 Aspartate Aminot
ransferase_PX28 17
35 Alkaline Phospha
tase_PX35 92
21 Bilirubin_PX21 0.31
47 Blood Urea Nitro
gen_PX47 42.3
6
48 Creatinine_PX48
0.73
Repeating
Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891064
Page 46 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Dec-2020 02:24
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category for
Lab TestVendor NameCollecti
on Date:Specim
en TypeLab ResultForm Instan
ce
2.CLINICAL C
HEMISTRY Ramos Mejia Hospital. General
Urquiza 609, Buenos Aires city
Dec/2/20
20 BLOOD
Sponsor-Defi
ned Identifie
rTest:Res
ult:
329 C Reactive Protei
n_PX329 33
30 Alanine Aminotr
ansferase_PX30 12
28 Aspartate Aminot
ransferase_PX28 17
35 Alkaline Phospha
tase_PX35 107
21 Bilirubin_PX21 0.46
47 Blood Urea Nitro
gen_PX47 [ ]
48 Creatinine_PX48
0.67
Repeating
Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891065
Page 47 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Ramos Mejia Hospital. General Urquiza 609, Buenos Aires city]
3.Collection Date: Dec/5/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [33]
Not Done:
LNMT Low
[UNK]
High
[UNK]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [24]
Not Done:
LNMT Low
[UNK]
High
[UNK]
Unit
U/L
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891066
Page 48 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [17]
Not Done:
LNMT Low
[UNK]
High
[UNK]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [92]
Not Done:
LNMT Low
[UNK]
High
[UNK]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.31]
Not Done:
LNMT Low
[UNK]
High
[UNK]
Unit
mg/dL
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891067
Page 49 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [42.36]
Not Done:
LNMT Low
[UNK]
High
[UNK]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.73]
Not Done:
LNMT Low
[UNK]
High
[UNK]
Unit
mg/dL
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891068
Page 50 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Ramos Mejia Hospital. General Urquiza 609, Buenos Aires city]
3.Collection Date: Dec/2/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [33]
Not Done:
LNMT Low
[0]
High
[7.00]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [12]
Not Done:
LNMT Low
[0]
High
[41]
Unit
U/L
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891069
Page 51 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [17]
Not Done:
LNMT Low
[0]
High
[40]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [107]
Not Done:
LNMT Low
[40]
High
[130]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.46]
Not Done:
LNMT Low
[0]
High
[1.20]
Unit
mg/dL
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891070
Page 52 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.67]
Not Done:
LNMT Low
[0.70]
High
[1.20]
Unit
mg/dL
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891071
Page 53 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category fo
r Lab TestVendor Name (DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.HEMATOL
OGY Ramos Mejia Hospital. General U
rquiza 609. Buenos Aires city. Dec/5/20
20 BLOOD Sponsor-Defin
ed IdentifierTest:Result
:
1 Hemoglobi
n_PX1 13
2 Hematocrit
_PX2 40
3 Erythrocyte
s_PX3 [ ]
5 Platelets_P
X5 47700
0000
7 Leukocytes
_PX7 56000
00
608 Neutrophils
_PX608 [ ]
609 Eosinophils
_PX609 [ ]
612 Monocytes
_PX612 [ ]
610 Basophils_
PX610 [ ]
611 Lymphocyt
es_PX611 [ ] Repeating
Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891072
Page 54 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Dec-2020 02:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category fo
r Lab TestVendor Name (DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
2.HEMATOL
OGY Ramos Mejia Hospital. General Ur
quiza 609, Buenos Aires city Dec/2/20
20 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
1 Hemoglobin
_PX1 12.7
2 Hematocrit_
PX2 38.4
3 Erythrocyte
s_PX3 4.41
5 Platelets_P
X5 370
7 Leukocytes
_PX7 11.4
6
608 Neutrophils
_PX608 3.78
609 Eosinophils
_PX609 0.14
612 Monocytes_
PX612 0.95
610 Basophils_P
X610 0.04
611 Lymphocyte
s_PX611 2.02
Repeating
Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891073
Page 55 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Ramos Mejia Hospital. General Urquiza 609. Buenos Aires city.]
3.Collection Date: Dec/5/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13]
Not Done:
LNMT Low
[unk]
High
[unk]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [40]
Not Done:
LNMT Low
[unk]
High
[unk]
Unit
%
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891074
Page 56 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [477000000]
Not Done:
LNMT Low
[unk]
High
[unk]
Unit
/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [5600000]
Not Done:
LNMT Low
[unk]
High
[unk]
Unit
/uL
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891075
Page 57 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891076
Page 58 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891077
Page 59 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Ramos Mejia Hospital. General Urquiza 609, Buenos Aires city]
3.Collection Date: Dec/2/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.7]
Not Done:
LNMT Low
[13.70]
High
[17.50]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [38.4]
Not Done:
LNMT Low
[40.1]
High
[51.0]
Unit
%
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891078
Page 60 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.41]
Not Done:
LNMT Low
[4.63]
High
[6.08]
Unit
10^12/L
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [370]
Not Done:
LNMT Low
[163]
High
[337]
Unit
10^9/L
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [11.46]
Not Done:
LNMT Low
[4.23]
High
[9.07]
Unit
10^9/L
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891079
Page 61 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [3.78]
Not Done:
LNMT Low
[1.78]
High
[5.38]
Unit
10^9/L
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.14]
Not Done:
LNMT Low
[0.04]
High
[0.54]
Unit
10^9/L
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.95]
Not Done:
LNMT Low
[0.3]
High
[0.82]
Unit
10^9/L
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891080
Page 62 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.04]
Not Done:
LNMT Low
[0.01]
High
[0.08]
Unit
10^9/L
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [2.02]
Not Done:
LNMT Low
[1.27]
High
[3.47]
Unit
10^9/L
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891081
Page 63 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891082
Page 64 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891083
Page 65 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891084
Page 66 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891085
Page 67 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891086
Page 68 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891087
Page 69 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891088
Page 70 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891089
Page 71 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date of A
ssessmentLocation of A
ssessmentImaging
MethodOverall AssessmentForm Instan
ce
1.Unknown CHEST CT SCA
N ABNORMAL
If abnormal, specify findings:
Basal fibrosis tracts with small left consolidation.The radiografy stud
y is referred by the volunteer. The result of the epicrisis does not appe
ar.
Repeating
Pages
2.Unknown CHEST X-RAY UNKNOWN Repeating
Pages
3.Dec/2/202
0 CHEST CT SCA
N ABNORMAL
If abnormal, specify findings:
Moderate pericardial effusion and left pleural effusion associated with
atelectasis of the underlying segments
Repeating
Pages
4.Nov/24/20
20 OTHER
If other, spec
ify:
Heart
ULTRAS
OUND ABNORMAL
If abnormal, specify findings:
Thickening of the parietal pericardium and occupation of the pericard
ial space with a structure of heterogeneous density
Repeating
Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891090
Page 72 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Unknown
//Comments
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Basal fibrosis tracts with small left consolidation.The radiografy study
is referred by the volunteer. The result of the epicrisis does not appear.]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891091
Page 73 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Unknown
//Comments
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: UNKNOWN
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891092
Page 74 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Dec/2/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Moderate pericardial effusion and left pleural effusion associated with atelectasis of
the underlying segments]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891093
Page 75 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/24/2020
2.Location of Assessment: OTHER
If other, specify:
[Heart]
3.Type of Imaging Exam: ULTRASOUND
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Thickening of the parietal pericardium and occupation of the pericardial space with a
structure of heterogeneous density]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891094
Page 76 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/29/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/29/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891095
Page 77 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/29/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTBR2]
5.bSample ID [BRVNND]
5.cSample ID [BRVNNF]
5.dSample ID [BRVNLY]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891096
Page 78 of 323
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891097
Page 79 of 323
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Unplanned Assessments
1.Assessments
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891098
Page 80 of 323
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/29/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891099
Page 81 of 323
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891100
Page 82 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891101
Page 83 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891102
Page 84 of 323
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891103
Page 85 of 323
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891104
Page 86 of 323
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891105
Page 87 of 323
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891106
Page 88 of 323
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891107
Page 89 of 323
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891108
Page 90 of 323
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891109
Page 91 of 323
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891110
Page 92 of 323
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891111
Page 93 of 323
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891112
Page 94 of 323
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891113
Page 95 of 323
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1. DELETED ADVERSE EV
ENT 1 Potential COVID-19 ill
nes Oct/17/2020 0
9:00 YES Repeating
Pages
2. ADVERSE EV
ENT 2 Gastroesophageal reflu
x disease Oct/30/2020 0
8:00 NO
End Date Time:
Dec/11/2020 18:39
Repeating
Pages
3. ADVERSE EV
ENT 3 Pericarditis Oct/17/2020 0
9:00 YES Repeating
Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891114
Page 96 of 323
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Potential COVID-19 illnes ]
4.Start Date Time: Oct/17/2020 09:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891115
Page 97 of 323
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[2020405021 ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891116
Page 98 of 323
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Gastroesophageal reflux disease]
4.Start Date Time: Oct/30/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/11/2020 18:39
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891117
Page 99 of 323
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891118
Page 100 of 323
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pericarditis]
4.Start Date Time: Oct/17/2020 09:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891119
Page 101 of 323
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
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[2020480698]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891120
Page 102 of 323
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891121
Page 103 of 323
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of Medication
Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891122
Page 104 of 323
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891123
Page 105 of 323
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891124
Page 106 of 323
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891125
Page 107 of 323
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891126
Page 108 of 323
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891127
Page 109 of 323
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891128
Page 110 of 323
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891129
Page 111 of 323
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891130
Page 112 of 323
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891131
Page 113 of 323
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Booster Dose Trigger Form
1.Select appropriate response - Will the
participant return for
consent/eligibility assessment for the
booster dose visit?
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891132
Page 114 of 323
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891133
Page 115 of 323
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891134
Page 116 of 323
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891135
Page 117 of 323
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/29/2020
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891136
Page 118 of 323
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891137
Page 119 of 323
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-24-2021 17:01:57 (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.
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0891138
Page 120 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-31-2020 17:43:57 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0891139
Page 121 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-31-2020 17:44:18 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0891140
Page 122 of 323
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormDec-30-2020 12:36:33 (UTC-03:00) City of Buenos
Aires
FormDec-21-2020 13:56:49 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891141
Page 123 of 323
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Dec-30-2020 12:36:33 (UTC-03:00) City of Buenos
Aires
1Dec-21-2020 13:56:49 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891142
Page 124 of 323
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Dec-30-2020 12:36:33 (UTC-03:00) City of Buenos
Aires
2Dec-21-2020 13:56:49 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891143
Page 125 of 323
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormDec-30-2020 12:37:21 (UTC-03:00) City of Buenos
Aires
FormDec-21-2020 13:57:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891144
Page 126 of 323
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Dec-30-2020 12:37:21 (UTC-03:00) City of Buenos
Aires
1Dec-21-2020 13:57:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891145
Page 127 of 323
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Dec-30-2020 12:37:21 (UTC-03:00) City of Buenos
Aires
2Dec-21-2020 13:57:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891146
Page 128 of 323
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Dec-30-2020 12:37:21 (UTC-03:00) City of Buenos
Aires
3Dec-21-2020 13:57:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891147
Page 129 of 323
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
4Dec-30-2020 12:37:21 (UTC-03:00) City of Buenos
Aires
4Dec-21-2020 13:57:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891148
Page 130 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6Oct-26-2020 11:01:36 (UTC-03:00) City of Buenos
AiresMaria Beretta NALT Unknown
6Oct-21-2020 15:29:56 (UTC-03:00) City of Buenos
AiresThe commercial kit used in the first sample is
unknown
Unknown
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0891149
Page 131 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Oct-21-2020 15:50:27 (UTC-03:00) City of Buenos
Airesunknown (not detailed in epicrisis)
Unknown
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0891150
Page 132 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Oct-26-2020 10:58:39 (UTC-03:00) City of Buenos
AiresMaria Beretta Unknown
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891151
Page 133 of 323
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-24-2021 17:01:57 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-23-2021 17:46:30 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-19-2021 14:28:08 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Adolfo Gonzalez N/A Mar-18-2021 15:49:40 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-11-2021 15:11:19 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0891152
Page 134 of 323
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-10-2021 16:38:46 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-18-2021 01:26:52 (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-29-2020 18:41:27 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-27-2020 07:35:00 (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.
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0891153
Page 135 of 323
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
N/A Nov-26-2020 18:15:17 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-06-2020 15:08:55 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-05-2020 06:58:41 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-04-2020 19:02:39 (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.
Adolfo Gonzalez N/A Nov-04-2020 17:16:12 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-03-2020 16:42:55 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0891154
Page 136 of 323
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-03-2020 09:33:25 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando Polack Approved Oct-30-2020 15:18:02 (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.
N/A Oct-30-2020 11:44:14 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-27-2020 18:54:18 (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.
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0891155
Page 137 of 323
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Julieta Gelardi N/A Oct-27-2020 16:32:36 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando Polack Approved Oct-27-2020 10:39:16 (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.
N/A Oct-26-2020 10:16:17 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-23-2020 20:06:14 (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.
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0891156
Page 138 of 323
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-31-2020 17:43:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-31-2020 17:43:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891157
Page 139 of 323
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-31-2020 17:43:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/31/2020Initial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891158
Page 140 of 323
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-31-2020 16:04:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12315632Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020 16:04:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1954Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020 17:43:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-31-2020 17:43:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-31-2020 17:43:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891159
Page 141 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020 17:43:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891160
Page 142 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-31-2020 17:44:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020 17:44:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-31-2020 17:44:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891161
Page 143 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020 17:44:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020 17:44:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
78.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-31-2020 17:44:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-31-2020 17:44:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
174.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-31-2020 17:44:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-31-2020 17:44:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.9Initial Entry
7.a
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891162
Page 144 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Aug-31-2020 17:44:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-31-2020 17:44:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-31-2020 17:44:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-31-2020 17:44:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-31-2020 17:44:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891163
Page 145 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-31-2020 17:44:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-31-2020 17:44:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
247322Initial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891164
Page 146 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 17:45:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 17:45:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 12:22:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-01-2020 04:47:30
(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.
Aug-31-2020 17:45:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-31-2020 17:45:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 12:22:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP264NInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891165
Page 147 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 12:22:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP264NInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020 12:22:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP264PInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020 12:22:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP264PInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020 12:22:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP264RInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020 12:22:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP264RInitial Entry
5.d
Date Location User Value Reason
Sep-01-2020 13:02:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
Sample ID: BNTWWSInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0891166
Page 148 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.d Sample ID
Date Location User Value Reason
Sep-01-2020 13:02:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
BNTWWSInitial Entry
5.e
Date Location User Value Reason
Sep-01-2020 13:02:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
Sample ID: BNTWWTInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-01-2020 13:02:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
BNTWWTInitial Entry
5.f
Date Location User Value Reason
Sep-01-2020 13:02:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
Sample ID: BNTWWVInitial Entry
5.f Sample ID
Date Location User Value Reason
Sep-01-2020 13:02:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
BNTWWVInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891167
Page 149 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 17:45:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 17:45:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 12:31:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-01-2020 04:47:30
(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.
Aug-31-2020 17:45:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-31-2020 17:45:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 12:31:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP25RCInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891168
Page 150 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 12:31:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP25RCInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891169
Page 151 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-31-2020 17:45:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020 17:45:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020 17:45:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020 17:45:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/31/2020 16:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020 17:45:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020 17:45:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891170
Page 152 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Aug-31-2020 17:45:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020 17:45:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-31-2020 17:45:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891171
Page 153 of 323
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-31-2020 17:45:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891172
Page 154 of 323
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-19-2020 15:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020Initial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891173
Page 155 of 323
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Sep-19-2020 16:00:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020Initial Entry
2.a
Date Location User Value Reason
Sep-19-2020 16:00:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.5
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-19-2020 16:00:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-19-2020 16:00:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-19-2020 16:00:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-19-2020 16:00:09
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(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-2021-5683-0891174
Page 156 of 323
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891175
Page 157 of 323
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-19-2020 16:00:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-19-2020 16:00:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-21-2020 09:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-20-2020 03:04:58
(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-19-2020 16:00:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-19-2020 16:00:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/19/2020Initial Entry
5.a
Date Location User Value Reason
Sep-21-2020 09:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPWF1MInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891176
Page 158 of 323
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a Sample ID
Date Location User Value Reason
Sep-21-2020 09:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPWF1MInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891177
Page 159 of 323
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-19-2020 16:00:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-19-2020 16:00:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-19-2020 16:00:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-19-2020 16:00:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020 14:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-19-2020 16:00:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-19-2020 16:00:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891178
Page 160 of 323
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Sep-19-2020 16:00:40
(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-19-2020 16:00:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-19-2020 16:00:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891179
Page 161 of 323
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User ValueReason
Jan-04-2021
01:57:47
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
2: Clo
sedAs per site confirmation -
updated PD tracker
Dec-31-2020
15:06:19
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Santiago Corradetti Query
2: Ans
weredDOV at V3 is indeed out of
window for 66 days from V2,
due to subject's
hospitalizations.
Dec-31-2020
02:36:01
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
2: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 66 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately.
Dec-30-2020
12:37:09
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data
Entry
:
Dec/2
9/202
0Initial Entry
Dec-30-2020
12:36:33
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data
Entry
:Initial Entry
Dec-21-2020
13:56:49
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
Nov-25-2020
13:47:28
(UTC-03:00)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (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)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891180
Page 162 of 323
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
City of
Buenos Aires
Nov-25-2020
13:19:02
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Maria Beretta Query
1: Ans
weredSubject continues participating
in the study but is actually
hospitalized due to respiratory
illness with no diagnosis.
Thank you
Nov-25-2020
12:19:43
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
1: Op
enedCLINQUERY: Please confirm
if subject will complete Visit 3
after COVID infection
resolution; else update the
EOT form as "no longer meets
eligibility criteria".
2. Erroneous Visit
Date Location User Value Reason
Dec-30-2020 12:36:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
Dec-21-2020 13:56:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891181
Page 163 of 323
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-30-2020 12:38:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
Dec-30-2020 12:37:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
Dec-21-2020 13:57:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-30-2020 12:38:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
Dec-30-2020 12:37:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
Dec-21-2020 13:57:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-30-2020 12:38:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
Dec-30-2020 12:37:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
Dec-21-2020 13:57:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (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)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891182
Page 164 of 323
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Dec-30-2020 12:38:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample is captured in the convalescent
visit wich was carried out the same da
yInitial Entry
Dec-30-2020 12:37:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
Dec-21-2020 13:57:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891183
Page 165 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-21-2020 15:33:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-21-2020 15:25:45
(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-21-2020 15:25:45
(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.
Oct-21-2020 15:25:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-21-2020 15:25:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891184
Page 166 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Oct/17/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Dec-11-2020 12:47:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolved:
Dec/7/2020New Information
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(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-2021-5683-0891185
Page 167 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Nov-29-2020 18:41:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:YESNew Information
Oct-21-2020 15:27:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-29-2020 18:41:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESNew Information
Oct-21-2020 15:27:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREASED S
HORTNESS OF BREATHInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(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-2021-5683-0891186
Page 168 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Symptom
Present:YES
4.c Symptoms:
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORTNESS
OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAINInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(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-2021-5683-0891187
Page 169 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Symptom P
resent:YES
4.e Symptoms:
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCLE PAI
NInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW LOSS OF TASTE
OR SMELL
Symptom P
resent:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-21-2020 15:27:55 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(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-2021-5683-0891188
Page 170 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City of Buenos
AiresSymptoms: NEW OR INCREASED
SORE THROAT
Symptom P
resent:NO
4.g Symptoms:
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE THRO
ATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-21-2020 15:27:55 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(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-2021-5683-0891189
Page 171 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City of Buenos
AiresSymptoms: VOMITING
Symptom Present: NO
4.i Symptoms:
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-21-2020 15:27:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891190
Page 172 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Oct-21-2020 15:31:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891191
Page 173 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Oct-21-2020 15:33:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891192
Page 174 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Oct-30-2020 11:44:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891193
Page 175 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Dec-11-2020 14:24:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891194
Page 176 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-21-2020 15:31:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-21-2020 15:31:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
RESPIRATORY SECRETIONSInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-21-2020 15:31:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-21-2020 15:31:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDROME
CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Oct-21-2020 15:31:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Oct-26-2020 17:18:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891195
Page 177 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-26-2020 11:03:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-26-2020 11:02:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Trade Name is Other,
however Trade Name
Other, Specify is not
completed. Please
update.
Oct-26-2020 11:02:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Oct-26-2020 11:02:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria Beretta Data Entry:
OTHERInitial Entry
Oct-26-2020 11:01:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria Beretta Data Entry: Initial Entry
Oct-24-2020 11:21:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened DM: Per response,
kindly consider to
update 'Trade name'
as other and update
"NALT Unknown" on
'Trade Name Other,
Specify:'.
Oct-23-2020 19:40:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered NALT unknown.
Oct-23-2020 07:01:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: As per CRF CR,
if trade name is not
known. Please select
"others" for this data
point and also update
"NALT Unknown" in
the other specified
field, Thank you.
Oct-21-2020 15:29:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UnknownInitial Entry
7. Test Result:
Date Location User Value Reason
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0891196
Page 178 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-21-2020 15:31:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Oct-26-2020 11:03:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria Beretta Data Entry:
NALT UnknownInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891197
Page 179 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-21-2020 15:33:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-21-2020 15:33:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-21-2020 15:33:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-21-2020 15:33:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDROME
CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Oct-21-2020 15:33:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Oct-21-2020 15:33:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
ATILA BIOSYSTEMS IAMP COVID-
19 DETECTION KITInitial Entry
7. Test Result:
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891198
Page 180 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Oct-21-2020 15:33:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891199
Page 181 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-30-2020 11:44:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Oct/28/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-30-2020 11:44:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-30-2020 11:44:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-30-2020 11:44:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDROME
CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Oct-30-2020 11:44:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Oct-30-2020 11:44:14
(UTC-03:00) City of BuenosACV0PFEINFP6000 Data Entry:
ATILA BIOSYSTEMS IAMP COVID-Initial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891200
Page 182 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aires 19 DETECTION KIT
7. Test Result:
Date Location User Value Reason
Oct-30-2020 11:44:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891201
Page 183 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Dec-11-2020 14:24:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Nov/30/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Dec-11-2020 14:24:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Dec-11-2020 14:24:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Dec-11-2020 14:24:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDROME
CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Dec-11-2020 14:24:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Dec-11-2020 14:24:59
(UTC-03:00) City of BuenosACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891202
Page 184 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aires
7. Test Result:
Date Location User Value Reason
Dec-11-2020 14:25:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Dec-11-2020 14:24:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
UnknownInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0891203
Page 185 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 15:33:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 15:33:32
(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-21-2020 15:33:32
(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-21-2020 15:33:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample collected by a team physicianInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891204
Page 186 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 15:33:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 15:33:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 08:49:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 15:33:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-21-2020 15:33:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020 08:49:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPT7WNInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891205
Page 187 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-22-2020 08:49:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPT7WNInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891206
Page 188 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.a
Date Location User Value Reason
Oct-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIAL
IST
Occurrence of Visits or C
ontacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: EMERGENC
Y ROOM
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891207
Page 189 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-21-2020 15:35:30
(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-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Oct-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Type of Practition
er:PRIMARY CAR
E PHYSICIAN
Occurrence of Visi
ts or Contacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Oct-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: URGENT C
AREInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(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-2021-5683-0891208
Page 190 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Occurrence of Visits or
Contacts:NO
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-21-2020 15:35:30
(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-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Type of Practition
er:TELEPHONE CO
NSULTATION
Occurrence of Vis
its or Contacts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-21-2020 15:35:30 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(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-2021-5683-0891209
Page 191 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City of Buenos
AiresType of Practition
er:OTHER
Occurrence of Vis
its or Contacts:YES
Number of Visits
or Contacts:
1
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-21-2020 15:35:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened “Other” is selected ,
however other specific
item is blank. Please
review and update as
appropriate.
Oct-21-2020 15:35:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
2. Other Type of Practitioner Specify:
Date Location User Value Reason
Oct-21-2020 15:35:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
home emergency serviceInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Oct-21-2020 15:36:17
(UTC-03:00) City of BuenosACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891210
Page 192 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aires Has the subject been in intensive care
due to potential COVID-19 illness?
NO
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891211
Page 193 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Oct-21-2020 15:36:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891212
Page 194 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Nov-26-2020 18:15:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891213
Page 195 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Oct-21-2020 15:36:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Oct-21-2020 15:36:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
HOSPITALInitial Entry
3. Admission Date:
Date Location User Value Reason
Oct-21-2020 15:36:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Oct/18/2020Initial Entry
4. Ongoing?
Date Location User Value Reason
Oct-21-2020 15:36:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NO
Discharge Date:
Oct/20/2020Initial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891214
Page 196 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Nov-26-2020 18:15:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Nov-30-2020 17:15:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Rupal N
ShahQuery 1: Closed Response satisfies
query
Nov-30-2020 14:20:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Query 1: Answered The volunteer remains
hospitalized. At the
moment there are no
epicrisis or objective
medical data, but the
volunteer reports that
he is admitted to a
general ward not in
intensive care. He
continues to be
monitored by the
medical surveillance
team.
Nov-29-2020 14:31:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Rupal N
ShahQuery 1: Opened CLIQUERY: This
subject was
hospitalized. Please
enter on the CRF form
any available
information (vital
signs, pulse oxymet,
respiratory treatment,
lab results,
imaging…). Please
make every effort to
obtain these
information
Nov-26-2020 18:15:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
HOSPITALInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0891215
Page 197 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
3. Admission Date:
Date Location User Value Reason
Nov-26-2020 18:15:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Nov/18/2020Initial Entry
4. Ongoing?
Date Location User Value Reason
Dec-11-2020 13:22:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
Discharge Date:
Dec/5/2020New Information
Nov-26-2020 18:15:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891216
Page 198 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-21-2020 15:39:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Dec-09-2020 14:26:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 2: Closed Response satisfies
query
Dec-08-2020 14:08:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New Information
Dec-08-2020 14:08:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
YES
Respiratory Illness Diagnosis:
Pericarditis
Date of Diagnosis:
Nov/24/2020New Information
Dec-06-2020 18:57:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 2: Opened Clin: please consider
updating the diagnosis
to PERICARDITIS or
to capture this as a
symptom on the SOD
CRF form.
Nov-30-2020 17:15:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Rupal N Shah Query 1: Closed Response satisfies
query
Nov-30-2020 14:22:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The volunteer remains
hospitalized. At the
moment there are no
epicrisis or objective
medical data, but the
volunteer reports that
he is hospitalized in a
general ward not in
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0891217
Page 199 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
intensive care. He
continues to be
monitored by the
medical surveillance
team.
Nov-30-2020 05:18:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLIQUERY: Given
that the subject has
been hospitalized,
please consider
updating diagnosis as
appropriate and
available.
Nov-29-2020 14:33:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Rupal N Shah Query 1: Candidate CLIQUERY: Given
that the subject has
been hospitalized,
please consider
updating diagnosis as
appropriate and
available.
Oct-21-2020 15:39:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-23-2020 21:27:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-23-2020 19:47:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-23-2020 19:47:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Transcription Error
Oct-23-2020 12:05:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CRA: please confirm
if Toxicity grade
should be 4, as subject
was hospitalized.
Thanks.
Oct-22-2020 08:50:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3New Information
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0891218
Page 200 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-21-2020 16:40:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0891219
Page 201 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Audit
Trail
Form Version: 21-Aug-2020 02:49 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Dec-11-2020 13:58:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891220
Page 202 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-15-2020 12:09:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
CLINICAL CHEMISTRYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Dec-11-2020 13:58:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Ramos Mejia Hospital. General Urquiz
a 609, Buenos Aires cityInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-16-2020 01:35:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-15-2020 12:09:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Dec-15-2020 12:09:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/5/2020Initial Entry
Dec-15-2020 11:20:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened DM: Please provide
a response to
Collection date field.
Thank you.
Dec-14-2020 10:58:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered good morning. The
date of the performed
laboratory was not
provided. Thank you
Dec-14-2020 03:21:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: Please complete
this item. Thank you.
4. Specimen Type:
Date Location User Value Reason
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891221
Page 203 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Dec-15-2020 12:09:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Dec-16-2020 13:05:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sponsor-Define
d Identifier:329
Test:: C Reactive Prote
in_PX329
Result:: 33
Not Done::
Lab Normal Ra
nge:Low
UNK
High
UNK
Unit
mg/LNew Information
Dec-11-2020 13:58:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:329
Test:: C Reactive Prot
ein_PX329
Result:: 33
Not Done::
Lab Normal Ra
nge:Low
UNK
High
UNKInitial Entry
5.a Sponsor ID:
Date Location User Value Reason
Dec-11-2020 13:58:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
329Initial Entry
5.a Test:
Date Location User Value Reason
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891222
Page 204 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Dec-11-2020 13:58:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
C Reactive Protein_PX329Initial Entry
5.a Result:
Date Location User Value Reason
Dec-17-2020 03:53:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed site confirm that
'Data is not in subject
record'
Dec-16-2020 13:05:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto Query
Dec-15-2020 07:46:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Please consider
to update the lab
normal ranges with
available unit from
the CRF options.
Kindly connect with
CRA for any further
assistance if needed.
Dec-14-2020 11:00:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered goor morning. Data
was not provided.
Thnk you
Dec-14-2020 08:23:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened DM: Thank you for
response. However
per CRF CR section
8.39.4, WBC
differentials should
be entered as absolute
values using 10^9/L
as units. Please
review and update
CRF as appropriate.
Else clarify in query
response.
Dec-11-2020 15:04:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Data is not in subject
record
Dec-11-2020 13:58:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Result is present, but
lab normal range
(Low, high or Unit) is
missing. Please
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891223
Page 205 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
correct or confirm.
Dec-11-2020 13:58:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
33Initial Entry
5.a LNMT
Date Location User Value Reason
Dec-16-2020 13:05:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
UNK
High
UNK
Unit
mg/LNew Information
Dec-11-2020 13:58:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
UNK
High
UNKInitial Entry
5.b
Date Location User Value Reason
Dec-11-2020 13:58:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:30
Test:: Alanine Aminotrans
ferase_PX30
Result:: 24
Not Done::
Lab Normal Ra
nge:Low
UNK
High
UNK
Unit
U/LInitial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0891224
Page 206 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.b Sponsor ID:
Date Location User Value Reason
Dec-11-2020 13:58:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30Initial Entry
5.b Test:
Date Location User Value Reason
Dec-11-2020 13:58:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Alanine Aminotransferase_PX30Initial Entry
5.b Result:
Date Location User Value Reason
Dec-11-2020 13:58:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
24Initial Entry
5.b LNMT
Date Location User Value Reason
Dec-11-2020 13:58:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Low
UNK
High
UNK
Unit
U/LInitial Entry
5.c
Date Location User Value Reason
Dec-11-2020 13:58:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:28
Test:: Aspartate Aminotran
sferase_PX28
Result:: 17Initial Entry
090177e196ae2ea1\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0891225
Page 207 of 323
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315632 Subject Initials: ---
Generated By: Generated Time (GMT): 29-M
…[truncated]