Document text
Page 1 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885485
Page 2 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/28/2020
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885486
Page 3 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Demography
1.Subject ID [12314759]
2.Birth Date: 1952
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885487
Page 4 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885488
Page 5 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885489
Page 6 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885490
Page 7 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type 2 Diabetes Mellitus]
Start Date: Nov/1/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Smoking]
Start Date: UNK/UNK/1972
Ongoing: NO
End Date:
Sep/UNK/2020
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Muscle cramps in calves]
Start Date: Jan/UNK/2020
Ongoing: YES
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885491
Page 8 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [100.9]
3.Unit: kg
4.Height: [166.0]
5.Unit: cm
6.Body Mass Index: [36.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885492
Page 9 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [244430]
3.Randomization Group: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885493
Page 10 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BLC5RT]
5.bSample ID [BLC5RV]
5.cSample ID [BPTD2L]
5.dSample ID [BPTD2M]
5.eSample ID [BPTD2N]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885494
Page 11 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BPTDMC]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885495
Page 12 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/28/2020 12:12
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
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885496
Page 13 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885497
Page 14 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885498
Page 15 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885499
Page 16 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP2BBW]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885500
Page 17 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/16/2020 11:24
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
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885501
Page 18 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885502
Page 19 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/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 [BLBKPM]
5.bSample ID [BLBKNX]
5.cSample ID [BP1PLF]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885503
Page 20 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885504
Page 21 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/5/2020
2.Date of First Symptom Started: Oct/10/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/1/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885505
Page 22 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885506
Page 23 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of C
ollectionSpecimen Typ
eSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Nov/5/202
0 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
2.Nov/11/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
3.Nov/26/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885507
Page 24 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/5/2020
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: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885508
Page 25 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/11/2020
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: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885509
Page 26 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/26/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX Comments
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: [NALT Unknown]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885510
Page 27 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Smaple collected by a team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885511
Page 28 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/5/2020
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 [BPT82R]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885512
Page 29 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[2]
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[2]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885513
Page 30 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Nov/26/2020 NO
Discharge Date:
Dec/1/2020
Repeating Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885514
Page 31 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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/26/2020
4.Ongoing? NO
Discharge Date:
Dec/1/2020
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885515
Page 32 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885516
Page 33 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885517
Page 34 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Restrictive ventilatory disability secondary to amyotrophic lateral sclerosis]
Date of Diagnosis:
Dec/22/2020
3.Toxicity Grade: 3
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885518
Page 35 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885519
Page 36 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885520
Page 37 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category for
Lab TestVendor NameCollecti
on Date:Specime
n TypeLab ResultForm Instan
ce
1.CLINICAL C
HEMISTRY Sanatorio del Oeste (Ol
azabal 319, Ituzaingo) Nov/27/
2020 BLOOD
Sponsor-Defi
ned IdentifierTest:Resu
lt:
329 C Reactive Protei
n_PX329 nega
tive
[ ] Alanine Aminotra
nsferase_PX30 [ ]
[ ] Aspartate Aminot
ransferase_PX28 [ ]
[ ] Alkaline Phospha
tase_PX35 [ ]
[ ] Bilirubin_PX21 [ ]
[ ] Blood Urea Nitro
gen_PX47 [ ]
[ ] Creatinine_PX48 [ ] Repeating
Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885521
Page 38 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Sanatorio del Oeste (Olazabal 319, Ituzaingo)]
3.Collection Date: Nov/27/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [negative]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [ ]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885522
Page 39 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.cSponsor ID: [ ]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [ ]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [ ]
Test: Bilirubin_PX21
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885523
Page 40 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5 fSponsor ID: [ ]
Test: Blood Urea Nitrogen_PX47
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [ ]
Test: Creatinine_PX48
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885524
Page 41 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category for
Lab TestVendor Name (DERIV
ED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.HEMATOLO
GY Sanatorio del Oeste, Olaz
abal 319 Ituzaingo. Nov/27/2
020 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
1 Hemoglobin
_PX1 15
2 Hematocrit_
PX2 43
3 Erythrocytes
_PX3 [ ]
5 Platelets_PX
5 [ ]
7 Leukocytes_
PX7 598
0
608 Neutrophils
_PX608 [ ]
609 Eosinophils
_PX609 [ ]
612 Monocytes_
PX612 [ ]
610 Basophils_P
X610 [ ]
611 Lymphocyte
s_PX611 [ ] Repeating
Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885525
Page 42 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Sanatorio del Oeste, Olazabal 319 Ituzaingo.]
3.Collection Date: Nov/27/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [15]
Not Done:
LNMT Low
[UNK]
High
[UNK]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [43]
Not Done:
LNMT Low
[UNK]
High
[UNK]
Unit
%
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885526
Page 43 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [5980]
Not Done:
LNMT Low
[UNK]
High
[UNK]
Unit
/uL
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885527
Page 44 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885528
Page 45 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885529
Page 46 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885530
Page 47 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885531
Page 48 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885532
Page 49 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885533
Page 50 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885534
Page 51 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885535
Page 52 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885536
Page 53 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885537
Page 54 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of A
ssessmen
tLocation of
AssessmentImaging
MethodOverall AssessmentForm Insta
nce
1.Nov/4/20
20 CHEST CT SCA
N ABNORMAL
If abnormal, specify findings:
Ground glass opacities are observed affecting both hemithorax wit
h multilobal involvement with a predominance of lower lobes.
Repeating
Pages
2.Nov/26/2
020 CHEST X-RAY UNKNOWN Repeating
Pages
3.Nov/29/2
020 CHEST CT SCA
N ABNORMAL
If abnormal, specify findings:
Bilateral laminar pleural effusion with a left predominance and sig
ns of adjacent passive atelectasis. Ground glass patterning density i
n lower lobes
Repeating
Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885538
Page 55 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/4/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Ground glass opacities are observed affecting both hemithorax with multilobal
involvement with a predominance of lower lobes.]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885539
Page 56 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/26/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: UNKNOWN
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885540
Page 57 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/29/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Bilateral laminar pleural effusion with a left predominance and signs of adjacent
passive atelectasis. Ground glass patterning density in lower lobes]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885541
Page 58 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/21/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/21/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885542
Page 59 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/21/2020
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 [BRVNCT]
5.bSample ID [BRVPDG]
5.cSample ID [BPW89F]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885543
Page 60 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885544
Page 61 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unplanned Assessments
1.Assessments
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885545
Page 62 of 245
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885546
Page 63 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885547
Page 64 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885548
Page 65 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885549
Page 66 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885550
Page 67 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885551
Page 68 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885552
Page 69 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885553
Page 70 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885554
Page 71 of 245
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885555
Page 72 of 245
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885556
Page 73 of 245
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/15/2021
2.Erroneous Visit
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885557
Page 74 of 245
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/15/2021
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885558
Page 75 of 245
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885559
Page 76 of 245
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Mar/15/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885560
Page 77 of 245
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/15/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRZ27V]
5.bSample ID [BRZ27G]
5.cSample ID [BRM9PM]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885561
Page 78 of 245
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/15/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR1LNW]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885562
Page 79 of 245
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/15/2021 13:43
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885563
Page 80 of 245
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885564
Page 81 of 245
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885565
Page 82 of 245
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885566
Page 83 of 245
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885567
Page 84 of 245
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885568
Page 85 of 245
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885569
Page 86 of 245
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885570
Page 87 of 245
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885571
Page 88 of 245
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885572
Page 89 of 245
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885573
Page 90 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Probable amyotrophic latera
l sclerosis Oct/10/2020 0
9:00 YES Repeating
Pages
2.ADVERSE EV
ENT 2 Pulmonary micronodules Nov/4/2020 0
9:00 NO
End Date Time:
Nov/29/2020 UNK:UN
K
Repeating
Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885574
Page 91 of 245
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Probable amyotrophic lateral sclerosis]
4.Start Date Time: Oct/10/2020 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
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885575
Page 92 of 245
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
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[2020478426]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885576
Page 93 of 245
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pulmonary micronodules]
4.Start Date Time: Nov/4/2020 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/29/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
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
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885577
Page 94 of 245
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885578
Page 95 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Categor
yMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
1. Repeating
Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885579
Page 96 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885580
Page 97 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885581
Page 98 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885582
Page 99 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885583
Page 100 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885584
Page 101 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885585
Page 102 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885586
Page 103 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885587
Page 104 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885588
Page 105 of 245
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/11/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885589
Page 106 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885590
Page 107 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885591
Page 108 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/19/2020
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885592
Page 109 of 245
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885593
Page 110 of 245
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885594
Page 111 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-28-2020 13:45:22 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885595
Page 112 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
3Nov-30-2020 10:11:48 (UTC-03:00) City of
Buenos Aires
3Nov-29-2020 11:51:21 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885596
Page 113 of 245
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormMar-15-2021 15:27:52 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0885597
Page 114 of 245
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-29-2021 14:17:39 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Yanina Rivera Approved Mar-17-2021 16:17:42 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, YaninaRivera, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-11-2021 11:13:41 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-17-2021 21:45:15 (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.
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885598
Page 115 of 245
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
N/A Feb-13-2021 10:55:51 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Maria Beretta Approved Feb-08-2021 16:43:36 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, MariaBeretta, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-04-2021 17:38:52 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Tatiana Estrada Approved Jan-21-2021 14:27:18 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, TatianaEstrada, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-29-2020 10:21:03 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885599
Page 116 of 245
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Fernando
Polack Approved Nov-16-2020 18:11:41 (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 Nov-16-2020 13:33:31 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-13-2020 10:56:25 (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.
Martina Davalli N/A Nov-12-2020 15:37:49 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Nov-11-2020 09:34:05 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885600
Page 117 of 245
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-10-2020 16:00:33 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-06-2020 18:43:11 (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-06-2020 12:03:16 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-26-2020 22:45:57 (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.
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885601
Page 118 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-28-2020 13:44:19
(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-28-2020 13:44:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885602
Page 119 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020 13:44:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/28/2020Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885603
Page 120 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020 13:00:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12314759Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020 13:00:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1952Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020 13:45:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020 13:45:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR O
F SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020 13:45:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885604
Page 121 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020 13:45:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885605
Page 122 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-28-2020 13:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020 13:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020 13:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885606
Page 123 of 245
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020 13:46:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:Type 2 Diabetes
Mellitus
Start Date: Nov/1/2017
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020 13:46:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 13:46:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type 2 Diabetes MellitusInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-28-2020 13:46:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/1/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020 13:46:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885607
Page 124 of 245
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Nov-16-2020 13:33:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Smoking
Start Date: UNK/UNK/19
72
Ongoing: NO
End Date:
Sep/UNK/2
020Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Nov-16-2020 13:33:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-16-2020 13:33:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SmokingInitial Entry
1.b Start Date:
Date Location User Value Reason
Nov-16-2020 13:33:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/1972Initial Entry
1.b Ongoing:
Date Location User Value Reason
Nov-16-2020 13:33:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
Sep/UNK/2020Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885608
Page 125 of 245
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.c
Date Location User Value Reason
Dec-31-2020 15:12:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Line/MH Num
ber:3
Medical Histor
y Term:Muscle cramps
in calves
Start Date: Jan/UNK/2020
Ongoing: YESInitial Entry
Dec-30-2020 12:20:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:Muscle cramps
in calves
Start Date: Jan/UNK/2020
Ongoing:Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885609
Page 126 of 245
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.c Line/MH Number:
Date Location User Value Reason
Dec-30-2020 12:20:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-30-2020 12:20:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Muscle cramps in calvesInitial Entry
1.c Start Date:
Date Location User Value Reason
Dec-30-2020 12:20:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/UNK/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Jan-04-2021 03:11:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-31-2020 15:12:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Dec-31-2020 15:12:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
YESInitial Entry
Dec-31-2020 06:11:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: Please
complete this item.
Thank you.
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885610
Page 127 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 13:46:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020 13:46:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
100.9Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020 13:46:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-28-2020 13:46:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
166.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020 13:46:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020 13:46:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
36.6Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885611
Page 128 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
7.a
Date Location User Value Reason
Aug-28-2020 13:46:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.1
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 13:46:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020 13:46:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020 13:46:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020 13:46:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885612
Page 129 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020 13:46:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020 13:46:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
244430Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885613
Page 130 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 13:47:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 13:47:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-30-2020 13:08:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 13:47:01
(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-28-2020 13:47:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-30-2020 13:08:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLC5RTInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885614
Page 131 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Aug-30-2020 13:08:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLC5RTInitial Entry
5.b
Date Location User Value Reason
Aug-30-2020 13:08:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLC5RVInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-30-2020 13:08:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLC5RVInitial Entry
5.c
Date Location User Value Reason
Aug-30-2020 13:24:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
Sample ID: BPTD2LInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-30-2020 13:24:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
BPTD2LInitial Entry
5.d
Date Location User Value Reason
Aug-30-2020 13:24:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
Sample ID: BPTD2MInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885615
Page 132 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.d Sample ID
Date Location User Value Reason
Aug-30-2020 13:24:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
BPTD2MInitial Entry
5.e
Date Location User Value Reason
Aug-30-2020 13:24:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
Sample ID: BPTD2NInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-30-2020 13:24:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
BPTD2NInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885616
Page 133 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 13:47:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 13:47:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-29-2020 13:24:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 13:47:07
(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-28-2020 13:47:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-29-2020 13:24:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPTDMCInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885617
Page 134 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Aug-29-2020 13:24:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPTDMCInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885618
Page 135 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020 13:47:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 13:47:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 13:47:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-28-2020 13:47:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/28/2020 12:12Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 13:47:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020 13:47:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885619
Page 136 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
7. Route:
Date Location User Value Reason
Aug-28-2020 13:47:19
(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-28-2020 13:47:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-28-2020 13:47:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885620
Page 137 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-28-2020 13:47:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885621
Page 138 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020 21:46:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885622
Page 139 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 21:47:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 21:47:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 36.9
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 21:47:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 21:47:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020 21:47:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885623
Page 140 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 21:47:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885624
Page 141 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 15:32:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 15:32:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020 15:33:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-16-2020 15:32:54
(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-16-2020 15:32:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020 15:33:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BP2BBWInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885625
Page 142 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 15:33:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BP2BBWInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885626
Page 143 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 21:47:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 21:47:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 21:47:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 21:47:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/16/2020 11:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 21:47:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020 21:47:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885627
Page 144 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
7. Route:
Date Location User Value Reason
Sep-18-2020 21:47:26
(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-18-2020 21:47:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-18-2020 21:47:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885628
Page 145 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020 12:21:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885629
Page 146 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 12:22:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 12:22:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 14:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 12:22:12
(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.
Oct-19-2020 12:22:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020 14:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLBKPMInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885630
Page 147 of 245
***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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Oct-19-2020 14:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLBKPMInitial Entry
5.b
Date Location User Value Reason
Oct-19-2020 16:05:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BLBKNXInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020 16:05:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BLBKNXInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020 16:53:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP1PLFInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020 16:53:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP1PLFInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885631
Page 148 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020 12:08:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-06-2020 12:03:15
(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.
Nov-06-2020 12:03:15
(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.
Nov-06-2020 12:03:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/5/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-06-2020 12:03:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885632
Page 149 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/5/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/10/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-17-2021 05:08:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-16-2021 19:28:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-16-2021 19:28:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolve
d:
Dec/1/2020New Information
Feb-15-2021 07:58:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Please confirm the
symptoms are still
ongoing for this
COVID Illness. If
all symptoms for
this illness are
resolved; please
update the Last
Symptoms Resolved
Date else clarify.
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0885633
Page 150 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:NOInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885634
Page 151 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.b Symptoms:
Date Location User Value Reason
Nov-06-2020 12:05:42
(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-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASED
SHORTNESS OF BREA
TH
Sympto
m Presen
t:YESInitial Entry
4.c Symptoms:
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORTNE
SS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885635
Page 152 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-06-2020 12:06:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:NOInitial Entry
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885636
Page 153 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.e Symptoms:
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCLE
PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-06-2020 12:06:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SMEL
LInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885637
Page 154 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires Symptoms
:NEW OR INCREASE
D SORE THROAT
Symptom
Present:NO
4.g Symptoms:
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE TH
ROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885638
Page 155 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-06-2020 12:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885639
Page 156 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Nov-06-2020 12:07:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885640
Page 157 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Nov-12-2020 15:37:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliForm Created
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885641
Page 158 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Nov-29-2020 10:22:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885642
Page 159 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-06-2020 12:07:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/5/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-06-2020 12:07:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-06-2020 12:07:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-06-2020 12:07:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Nov-06-2020 12:07:04
(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
Nov-06-2020 12:07:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ATILA BIOSYSTEMS IAMP COV
ID-19 DETECTION KITInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885643
Page 160 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
7. Test Result:
Date Location User Value Reason
Nov-06-2020 12:07:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885644
Page 161 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-12-2020 15:37:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Nov/11/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-12-2020 15:37:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-12-2020 15:37:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-12-2020 15:37:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Nov-12-2020 15:37:49
(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
Nov-12-2020 15:37:49
(UTC-03:00) City ofACV0PFEINFP6000 Martina
DavalliData Entry:
ATILA BIOSYSTEMS IAMP COInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885645
Page 162 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires VID-19 DETECTION KIT
7. Test Result:
Date Location User Value Reason
Nov-12-2020 15:37:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NEGATIVEInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885646
Page 163 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-29-2020 10:22:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/26/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-29-2020 10:22:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User ValueReason
Nov-30-2020
17:49:49
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_MBMIB002_03
Nov-30-2020
10:14:40
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Nov-30-2020
10:14:40
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data
Entry
:
NAS
OPH
ARY
NXTranscription Error
Nov-30-2020
10:11:48
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data
Entry
:Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885647
Page 164 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Nov-30-2020
02:23:29
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6268902;Specimen
Collection Location is
not expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Nov-29-2020
11:51:21
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-29-2020 10:22:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Nov-29-2020 10:22:54
(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
Nov-29-2020 10:22:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Nov-29-2020 10:22:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885648
Page 165 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
9. Trade Name Other, Specify:
Date Location User Value Reason
Nov-29-2020 10:22:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NALT UnknownInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885649
Page 166 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-06-2020 12:07:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020 12:07:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020 12:07:40
(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
Nov-06-2020 12:07:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Smaple collected by a team physicia
nInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885650
Page 167 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-06-2020 12:08:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020 12:08:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020 13:38:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-06-2020 12:08:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Nov-06-2020 12:08:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
Nov-06-2020 13:38:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPT82RInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885651
Page 168 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Nov-06-2020 13:38:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPT82RInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885652
Page 169 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Dec-03-2020 12:26:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina Davalli Data Entry:
Type of Practi
tioner:SPECIALIST
Occurrence of
Visits or Cont
acts:YES
Number of Vi
sits or Conta
cts:
2New Information
Dec-02-2020 13:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practi
tioner:SPECIALIST
Occurrence of
Visits or Cont
acts:YES
Number of Vi
sits or Conta
cts:
1New Information
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-03-2020 12:26:08
(UTC-03:00) City ofACV0PFEINFP6000 Martina Davalli Data Entry:
YESNew Information
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885653
Page 170 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires Number of Visits or Contacts:
2
Dec-02-2020 13:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Contacts:
1New Information
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Dec-02-2020 13:16:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practi
tioner:EMERGENCY
ROOM
Occurrence of
Visits or Cont
acts:YES
Number of Vi
sits or Conta
cts:
2New Information
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practi
tioner:EMERGENCY
ROOM
Occurrence of
Visits or Cont
acts:YES
Number of Vi
sits or Conta
cts:
1Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885654
Page 171 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-02-2020 13:16:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Contacts:
2New Information
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.c
Date Location User Value Reason
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:PRIMARY CA
RE PHYSICIA
N
Occurrence of Vi
sits or Contacts:NOInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885655
Page 172 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-06-2020 12:08:43
(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
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Nov-06-2020 12:08:43
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885656
Page 173 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires Type of Practitio
ner:TELEPHONE C
ONSULTATION
Occurrence of V
isits or Contacts:NO
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or C
ontacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (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-2021-5683-0885657
Page 174 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Nov-29-2020 10:21:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Has the subject been in intensive
care due to potential COVID-19 il
lness?
NONew Information
Nov-06-2020 12:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885658
Page 175 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Nov-29-2020 10:21:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885659
Page 176 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Nov-29-2020 10:21:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Dec-07-2020 13:46:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Rupal N
ShahQuery 1: Closed Response satisfies
query
Dec-03-2020 12:38:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Available
information is
entered in CRF.
Thank you.
Dec-02-2020 02:05:01
(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-29-2020 10:21:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HOSPITALInitial Entry
3. Admission Date:
Date Location User Value Reason
Nov-29-2020 10:21:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/26/2020Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885660
Page 177 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4. Ongoing?
Date Location User Value Reason
Dec-03-2020 12:11:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NO
Discharge Date:
Dec/1/2020New Information
Nov-29-2020 10:21:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885661
Page 178 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Nov-06-2020 12:09:06
(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
Feb-23-2021 21:21:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Feb-04-2021 17:38:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered New Information
Feb-04-2021 17:38:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness Diagnosis:
Restrictive ventilatory disabi
lity secondary to amyotrophi
c lateral sclerosis
Date of Diagnosis:
Dec/22/2020New Information
Feb-01-2021 23:34:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Opened Clinical COPD was
diagnosed 28Nov20
(not exacerbated);
also review new dx
of ALS for
Respiratory Illness
diagnosis
Dec-11-2020 17:43:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Dec-11-2020 17:17:44
(UTC-03:00) City ofACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0885662
Page 179 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
Dec-11-2020 17:17:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
YES
Respiratory Illness Diagnosis:
exacerbation of chronic obst
ructive pulmonary disease
Date of Diagnosis:
Nov/28/2020Transcription Error
Dec-11-2020 12:26:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened Clinical - Date of
diagnosis for COPD
is given as 01Dec20;
however, this is the
discharge date at end
of hospitalization,
not diagnosis date.
Please enter
diagnosis date for
new condition
COPD
Dec-04-2020 12:50:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness Diagnosis:
exacerbation of chronic obst
ructive pulmonary disease
Date of Diagnosis:
Dec/1/2020New Information
Nov-10-2020 21:39:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-10-2020 21:16:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness Diagnosis:
pneumonia
Date of Diagnosis:Transcription Error
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885663
Page 180 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Nov/4/2020
Nov-10-2020 21:15:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Nov-10-2020 21:15:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness Diagnosis:
pneumonia
Date of Diagnosis:
Nov/10/2020New Information
Nov-10-2020 18:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Please consider
update diagnosis,
since this subject
undergone CT Scan
and antibiotics
treatment. Thank
you!
Nov-06-2020 12:09:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Dec-22-2020 09:39:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Nicole
ZalchendlerQuery 2: Closed Response satisfies
query
Dec-21-2020 19:18:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed
Information
Dec-21-2020 19:18:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Changed
Information
Dec-17-2020 18:57:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened CRA: Please
consider Toxicity
grade due to subject
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (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)
FDA-CBER-2021-5683-0885664
Page 181 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
was hospitalized.
Thanks.
Nov-10-2020 21:38:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-10-2020 18:58:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-10-2020 18:58:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Transcription Error
Nov-10-2020 18:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CRA: Please
consider Toxicity
grade due to subject
attended to
Emergency Care.
Thank you!
Nov-06-2020 12:09:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885665
Page 182 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: 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: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiForm Created
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885666
Page 183 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-21-2020 15:14:13
(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-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sanatorio del Oeste (Olazabal 319
, Ituzaingo)Initial Entry
3. Collection Date:
Date Location User Value Reason
Dec-22-2020 09:33:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Nicole
ZalchendlerQuery 1: Closed Response satisfies
query
Dec-21-2020 19:33:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Dec-21-2020 19:33:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered good afternoon As
figured in medical
recored C reactive
protein during the in
patint status was
negative. Thank you
Dec-21-2020 17:22:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Nicole
ZalchendlerQuery 1: Reissued:Opened Thank you for your
reply. Please note
that C Reactive
Protein_PX329
result is still
incomplete. Thank
you.
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Collection date is
updated, but result is
missing. Please
correct or confirm.
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885667
Page 184 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Nov/27/2020Initial Entry
Dec-21-2020 12:53:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened Thank you for your
response. Please note
the results to be
included is from the
test C Reactive
Protein, in Sanatorio
del Oeste. Thank
you!
Dec-20-2020 19:10:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The results of the
PCR done during
hospitalization were
uploaded to the
COVID TEST form.
Dec-17-2020 18:49:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CRA: please include
the result of PCR,
done during
hospitalization.
Thanks.
4. Specimen Type:
Date Location User Value Reason
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Dec-21-2020 19:33:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:329
Test:: C Reactive Pro
tein_PX329
Result:: negativeInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885668
Page 185 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Not Done::
Lab Normal Ra
nge:
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sponsor-Define
d Identifier:
Test:: C Reactive Pro
tein_PX329
Result::
Not Done::
Lab Normal Ra
nge:Initial Entry
5.a Sponsor ID:
Date Location User Value Reason
Dec-21-2020 19:33:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
329Initial Entry
5.a Test:
Date Location User Value Reason
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
C Reactive Protein_PX329Initial Entry
5.a Result:
Date Location User Value Reason
Dec-22-2020 02:58:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-21-2020 19:35:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered nominal value was
not provided Thank
you
Dec-21-2020 19:33:55
(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.
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885669
Page 186 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Please correct or
confirm.
Dec-21-2020 19:33:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
negativeInitial Entry
5.b
Date Location User Value Reason
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sponsor-Defin
ed Identifier:
Test:: Alanine Aminotr
ansferase_PX30
Result::
Not Done::
Lab Normal
Range:Initial Entry
5.b Test:
Date Location User Value Reason
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Alanine Aminotransferase_PX30Initial Entry
5.c
Date Location User Value Reason
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sponsor-Defi
ned Identifier
:
Test:: Aspartate Amino
transferase_PX2
8
Result::
Not Done::
Lab Normal
Range:Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885670
Page 187 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c Test:
Date Location User Value Reason
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Aspartate Aminotransferase_PX2
8Initial Entry
5.d
Date Location User Value Reason
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sponsor-Define
d Identifier:
Test:: Alkaline Phosp
hatase_PX35
Result::
Not Done::
Lab Normal R
ange:Initial Entry
5.d Test:
Date Location User Value Reason
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Alkaline Phosphatase_PX35Initial Entry
5.e
Date Location User Value Reason
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sponsor-Defined Id
entifier:
Test:: Bilirubin_P
X21
Result::
Not Done::
Lab Normal Range
:Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885671
Page 188 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.e Test:
Date Location User Value Reason
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Bilirubin_PX21Initial Entry
5.f
Date Location User Value Reason
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sponsor-Define
d Identifier:
Test:: Blood Urea Nit
rogen_PX47
Result::
Not Done::
Lab Normal Ra
nge:Initial Entry
5.f Test:
Date Location User Value Reason
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Blood Urea Nitrogen_PX47Initial Entry
5.g
Date Location User Value Reason
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sponsor-Defined I
dentifier:
Test:: Creatinine_
PX48
Result::
Not Done::
Lab Normal Range
:Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885672
Page 189 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.g Test:
Date Location User Value Reason
Dec-21-2020 15:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Creatinine_PX48Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885673
Page 190 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Audit Trail
Form Version: 21-Aug-2020 02:51 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885674
Page 191 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HEMATOLOGYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sanatorio del Oeste, Olazabal 319 I
tuzaingo.Initial Entry
3. Collection Date:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/27/2020Initial Entry
4. Specimen Type:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:1
Test:: Hemoglobin_
PX1
Result:: 15
Not Done::Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885675
Page 192 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Lab Normal Range: Low
UNK
High
UNK
Unit
g/dL
5.a Sponsor ID:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
5.a Test:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Hemoglobin_PX1Initial Entry
5.a Result:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
5.a LNMT
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
UNK
High
UNK
Unit
g/dLInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885676
Page 193 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.b
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Ide
ntifier:2
Test:: Hematocrit_
PX2
Result:: 43
Not Done::
Lab Normal Range: Low
UNK
High
UNK
Unit
%Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885677
Page 194 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.b Sponsor ID:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
5.b Test:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Hematocrit_PX2Initial Entry
5.b Result:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
43Initial Entry
5.b LNMT
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
UNK
High
UNK
Unit
%Initial Entry
5.c
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:3
Test:: Erythrocytes
_PX3Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885678
Page 195 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Result::
Not Done:: NOT DONE
Lab Normal Range:
5.c Sponsor ID:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
5.c Test:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Erythrocytes_PX3Initial Entry
5.c Not Done:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.d
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Iden
tifier:5
Test:: Platelets_P
X5
Result::
Not Done:: NOT DON
E
Lab Normal Range:Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885679
Page 196 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.d Sponsor ID:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
5.d Test:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Platelets_PX5Initial Entry
5.d Not Done:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.e
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Ide
ntifier:7
Test:: Leukocytes_
PX7
Result:: 5980
Not Done::
Lab Normal Range: Low
UNK
High
UNK
Unit
/uLInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885680
Page 197 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.e Sponsor ID:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
5.e Test:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Leukocytes_PX7Initial Entry
5.e Result:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
5980Initial Entry
5.e LNMT
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Low
UNK
High
UNK
Unit
/uLInitial Entry
5.f
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:608
Test:: Neutrophils_P
X608Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885681
Page 198 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Result::
Not Done:: NOT DONE
Lab Normal Range
:
5.f Sponsor ID:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
608Initial Entry
5.f Test:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Neutrophils_PX608Initial Entry
5.f Not Done:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.g
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:609
Test:: Eosinophils_P
X609
Result::
Not Done:: NOT DONE
Lab Normal Range
:Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885682
Page 199 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.g Sponsor ID:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
609Initial Entry
5.g Test:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Eosinophils_PX609Initial Entry
5.g Not Done:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.h
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:612
Test:: Monocytes_P
X612
Result::
Not Done:: NOT DONE
Lab Normal Range:Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885683
Page 200 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.h Sponsor ID:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
612Initial Entry
5.h Test:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Monocytes_PX612Initial Entry
5.h Not Done:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.i
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Ide
ntifier:610
Test:: Basophils_P
X610
Result::
Not Done:: NOT DONE
Lab Normal Range:Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885684
Page 201 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.i Sponsor ID:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
610Initial Entry
5.i Test:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Basophils_PX610Initial Entry
5.i Not Done:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.j
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:611
Test:: Lymphocytes_
PX611
Result::
Not Done:: NOT DONE
Lab Normal Rang
e:Initial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885685
Page 202 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.j Sponsor ID:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
611Initial Entry
5.j Test:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Lymphocytes_PX611Initial Entry
5.j Not Done:
Date Location User Value Reason
Dec-03-2020 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885686
Page 203 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: IMAGING - Audit Trail
Form Version: 06-Jul-2020 21:53 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Nov-10-2020 16:00:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0885687
Page 204 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: IMAGING - Audit Trail
Form Version: 06-Jul-2020 21:53 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Nov-29-2020 10:23:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885688
Page 205 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: IMAGING - Audit Trail
Form Version: 06-Jul-2020 21:53 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Dec-04-2020 14:27:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2edc\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885689
Page 206 of 245
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/05/2020Form: IMAGING - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314759 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-10-2020 16:00:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/4/2020Initial Entry
2. Location of Assessment:
Date Location User Value Reason
…[truncated]