125742 S1 M5 CRF c4591001 1231 12315622

Document text

Page 1 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890770
Page 2 of 250
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/31/2020
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890771
Page 3 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Demography
1.Subject ID [12315622]
2.Birth Date: /1996
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0890772
Page 4 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890773
Page 5 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890774
Page 6 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890775
Page 7 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890776
Page 8 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [71.0]
3.Unit: kg
4.Height: [182.0]
5.Unit: cm
6.Body Mass Index: [21.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890777
Page 9 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [75546]
3.Randomization Group: [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890778
Page 10 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP263N]
5.bSample ID [BP263P]
5.cSample ID [BP263R]
5.dSample ID [BNTWVY]
5.eSample ID [BNTWVZ]
5.fSample ID [BNTWW0]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890779
Page 11 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP25R1]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890780
Page 12 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/31/2020 16:04
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
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890781
Page 13 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890782
Page 14 of 250
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/19/2020
2.Erroneous Visit
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890783
Page 15 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Sep/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890784
Page 16 of 250
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/19/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWDXW]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890785
Page 17 of 250
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/19/2020 10:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890786
Page 18 of 250
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890787
Page 19 of 250
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNTWFX]
5.bSample ID [BNTWG0]
5.cSample ID [BPW5RT]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890788
Page 20 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890789
Page 21 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/22/2021
2.Date of First Symptom Started: Jan/9/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/11/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890790
Page 22 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
5.aSymptoms - Other Text: [nausea]
5.bSymptoms - Other Text: [abdominal pain]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890791
Page 23 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890792
Page 24 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890793
Page 25 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[covid visit performed more than 5 days after symptoms resolved]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890794
Page 26 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[covid visit performed more than 5 days after symptoms resolved]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890795
Page 27 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890796
Page 28 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Jan/9/2021  NO
Discharge Date:
Jan/11/2021
 Repeating Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890797
Page 29 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Jan/9/2021
4.Ongoing? NO
Discharge Date:
Jan/11/2021
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890798
Page 30 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890799
Page 31 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890800
Page 32 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[gastroenterocolitis]
Date of Diagnosis:
Jan/9/2021
3.Toxicity Grade: 3
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890801
Page 33 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890802
Page 34 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890803
Page 35 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category f
or Lab TestVendor NameCollect
ion Dat
e:Specim
en Typ
eLab ResultForm Insta
nce
 1.CLINICAL
CHEMIST
RY Sanatorio Santa Barbara, Portel
a 2975, Ciudad Autonoma de B
uenos Aires Jan/9/2
021 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
329  C Reactive Pro
tein_PX329 [ ] 
30  Alanine Amin
otransferase_P
X30 16 
28  Aspartate Ami
notransferase_
PX28 19 
35  Alkaline Phosp
hatase_PX35 216
 
21  Bilirubin_PX2
1 1.8 
47  Blood Urea Nit
rogen_PX47 [ ] 
48  Creatinine_PX
48 [ ] Repeating
Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890804
Page 36 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Sanatorio Santa Barbara, Portela 2975, Ciudad Autonoma de Buenos Aires]
3.Collection Date: Jan/9/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [16]
Not Done:
LNMT Low
[4]
High
[40]
Unit
U/L
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890805
Page 37 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [19]
Not Done:
LNMT Low
[4]
High
[40]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [216]
Not Done:
LNMT Low
[0]
High
[300]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [1.8]
Not Done:
LNMT Low
[0]
High
[1]
Unit
mg/dL
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890806
Page 38 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890807
Page 39 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category f
or Lab Tes
tVendor Name (DERIVED)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.HEMATO
LOGY Sanatorio Santa Barbara, Portela 2
975, Ciudad Autonoma de Buenos
Aires Feb/9/2
021 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
1  Hemoglob
in_PX1 16.
4 
2  Hematocri
t_PX2 50 
3  Erythrocyt
es_PX3 [ ] 
5  Platelets_
PX5  
7  Leukocyte
s_PX7 23.
3 
608  Neutrophil
s_PX608 87 
609  Eosinophil
s_PX609 [ ] 
612  Monocyte
s_PX612 [ ] 
610  Basophils
_PX610 [ ] 
611  Lymphocy
tes_PX611
 [ ] Repeating
Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890808
Page 40 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Sanatorio Santa Barbara, Portela 2975, Ciudad Autonoma de Buenos Aires]
3.Collection Date: Feb/9/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [16.4]
Not Done:
LNMT Low
[12]
High
[16.8]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [50]
Not Done:
LNMT Low
[36]
High
[52]
Unit
%
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890809
Page 41 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [23.3]
Not Done:
LNMT Low
[4]
High
[10]
Unit
10^9/L
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890810
Page 42 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [87]
Not Done:
LNMT Low
[50]
High
[70]
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
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890811
Page 43 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890812
Page 44 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890813
Page 45 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890814
Page 46 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890815
Page 47 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890816
Page 48 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890817
Page 49 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890818
Page 50 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890819
Page 51 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890820
Page 52 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890821
Page 53 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: IMAGING
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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890822
Page 54 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/03/2021Form: 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890823
Page 55 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/03/2021Form: 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/3/2021
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 [BLBX33]
5.bSample ID [BLBX2R]
5.cSample ID [BR23VC]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890824
Page 56 of 250
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890825
Page 57 of 250
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Unplanned Assessments
1.Assessments
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890826
Page 58 of 250
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890827
Page 59 of 250
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890828
Page 60 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890829
Page 61 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890830
Page 62 of 250
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890831
Page 63 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890832
Page 64 of 250
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890833
Page 65 of 250
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890834
Page 66 of 250
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890835
Page 67 of 250
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/11/2021
2.Erroneous Visit
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890836
Page 68 of 250
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890837
Page 69 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/20/2021
2.Erroneous Visit
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890838
Page 70 of 250
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/20/2021
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890839
Page 71 of 250
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890840
Page 72 of 250
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Feb/20/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890841
Page 73 of 250
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/20/2021
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 [BR21L3]
5.bSample ID [BLBXS7]
5.cSample ID [BLBXSN]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890842
Page 74 of 250
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/20/2021
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 [BRM9JD]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890843
Page 75 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/20/2021 16:04
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
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890844
Page 76 of 250
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890845
Page 77 of 250
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/11/2021
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 [BR1WK0]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890846
Page 78 of 250
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/11/2021 11:20
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
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890847
Page 79 of 250
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890848
Page 80 of 250
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890849
Page 81 of 250
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890850
Page 82 of 250
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890851
Page 83 of 250
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890852
Page 84 of 250
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890853
Page 85 of 250
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890854
Page 86 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1  gastroenterocoliti
s Jan/9/2021 09:0
0 NO
End Date Time:
Jan/11/2021 17:00
 Repeating
Pages
 2.ADVERSE EVE
NT 2  Vomiting  Feb/21/2021 08
:00 NO
End Date Time:
Feb/21/2021 10:00
 Repeating
Pages
 3.ADVERSE EVE
NT 3  Pain at injection s
ite. Feb/21/2021 08
:00 NO
End Date Time:
Feb/21/2021 22:00
 Repeating
Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890855
Page 87 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[gastroenterocolitis]
4.Start Date Time: Jan/9/2021 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/11/2021 17:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890856
Page 88 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
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[2021191938]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890857
Page 89 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Vomiting]
4.Start Date Time: Feb/21/2021 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/21/2021 10:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890858
Page 90 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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[ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890859
Page 91 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pain at injection site.]
4.Start Date Time: Feb/21/2021 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/21/2021 22:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890860
Page 92 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? 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[ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890861
Page 93 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890862
Page 94 of 250
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890863
Page 95 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890864
Page 96 of 250
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890865
Page 97 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890866
Page 98 of 250
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890867
Page 99 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890868
Page 100 of 250
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890869
Page 101 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890870
Page 102 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890871
Page 103 of 250
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/11/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890872
Page 104 of 250
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890873
Page 105 of 250
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890874
Page 106 of 250
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/22/2020
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890875
Page 107 of 250
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890876
Page 108 of 250
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-11-2021 15:11:03 (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.
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0890877
Page 109 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-31-2020 17:25:13 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890878
Page 110 of 250
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-31-2020 17:26:01 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890879
Page 111 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormMar-01-2021 10:29:05 (UTC-03:00) City of
Buenos Airescovid visit performed more than 5 days after
symptoms resolved
Not Done
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890880
Page 112 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Mar-01-2021 10:29:05 (UTC-03:00) City of
Buenos Airescovid visit performed more than 5 days after
symptoms resolved
Not Done
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890881
Page 113 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Mar-01-2021 10:29:05 (UTC-03:00) City of
Buenos Airescovid visit performed more than 5 days after
symptoms resolved
Not Done
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890882
Page 114 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Mar-01-2021 10:29:05 (UTC-03:00) City of
Buenos Airescovid visit performed more than 5 days after
symptoms resolved
Not Done
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890883
Page 115 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
4Mar-01-2021 10:29:05 (UTC-03:00) City of
Buenos Airescovid visit performed more than 5 days after
symptoms resolved
Not Done
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890884
Page 116 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
5Mar-01-2021 10:29:05 (UTC-03:00) City of
Buenos Airescovid visit performed more than 5 days after
symptoms resolved
Not Done
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890885
Page 117 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6Mar-01-2021 10:29:05 (UTC-03:00) City of
Buenos Airescovid visit performed more than 5 days after
symptoms resolved
Not Done
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890886
Page 118 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
7Mar-01-2021 10:29:05 (UTC-03:00) City of
Buenos Airescovid visit performed more than 5 days after
symptoms resolved
Not Done
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890887
Page 119 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
8Mar-01-2021 10:29:05 (UTC-03:00) City of
Buenos Airescovid visit performed more than 5 days after
symptoms resolved
Not Done
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890888
Page 120 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
9Mar-01-2021 10:29:05 (UTC-03:00) City of
Buenos Airescovid visit performed more than 5 days after
symptoms resolved
Not Done
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890889
Page 121 of 250
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormFeb-21-2021 11:36:30 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0890890
Page 122 of 250
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-11-2021 15:11:03 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-11-2021 13:27:44 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-06-2021 09:45:46 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-21-2021 11:36:08 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0890891
Page 123 of 250
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Yanina Rivera  Approved Feb-18-2021 16:01:29 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, YaninaRivera, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
  N/A Feb-11-2021 16:58:19 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-26-2020 19:26:40 (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.
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0890892
Page 124 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-31-2020 17:24:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-31-2020 17:24:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890893
Page 125 of 250
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-31-2020 17:24:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/31/2020Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890894
Page 126 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-31-2020 15:34:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12315622Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020 15:34:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1996Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020 17:24:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-31-2020 17:24:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-31-2020 17:24:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890895
Page 127 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020 17:25:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890896
Page 128 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-31-2020 17:25:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020 17:25:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-31-2020 17:25:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890897
Page 129 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020 17:26:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020 17:26:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
71.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-31-2020 17:26:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-31-2020 17:26:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
182.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-31-2020 17:26:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-31-2020 17:26:24 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890898
Page 130 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City of
Buenos Aires(autocalc) 21.4
7.a
Date Location User Value Reason
Aug-31-2020 17:26:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 36.7
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-31-2020 17:26:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-31-2020 17:26:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-31-2020 17:26:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-31-2020 17:26:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890899
Page 131 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-31-2020 17:26:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-31-2020 17:26:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
75546Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890900
Page 132 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 17:26:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 17:26:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 12:02:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-01-2020 04:47:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-31-2020 17:26:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-31-2020 17:26:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890901
Page 133 of 250
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a
Date Location User Value Reason
Sep-01-2020 12:02:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP263NInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 12:02:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP263NInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020 12:02:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP263PInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020 12:02:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP263PInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020 12:02:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP263RInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020 12:02:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP263RInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890902
Page 134 of 250
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.d
Date Location User Value Reason
Sep-01-2020 12:56:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNTWVYInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-01-2020 12:56:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNTWVYInitial Entry
5.e
Date Location User Value Reason
Sep-01-2020 12:57:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNTWVZInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-01-2020 12:57:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNTWVZInitial Entry
5.f
Date Location User Value Reason
Sep-01-2020 12:58:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNTWW0Initial Entry
5.f Sample ID
Date Location User Value Reason
Sep-01-2020 12:58:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNTWW0Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890903
Page 135 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 17:26:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 17:26:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 12:25:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-01-2020 04:47:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-31-2020 17:26:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-31-2020 17:26:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890904
Page 136 of 250
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a
Date Location User Value Reason
Sep-01-2020 12:25:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP25R1Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 12:25:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP25R1Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890905
Page 137 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-31-2020 17:26:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020 17:26:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020 17:26:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020 17:26:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/31/2020 16:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020 17:26:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020 17:26:59 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0890906
Page 138 of 250
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City of
Buenos AiresLEFT
7. Route:
Date Location User Value Reason
Aug-31-2020 17:26:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020 17:26:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-31-2020 17:26:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890907
Page 139 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-31-2020 17:27:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890908
Page 140 of 250
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-19-2020 12:27:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/19/2020Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890909
Page 141 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Sep-19-2020 12:27:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/19/2020Initial Entry
2.a
Date Location User Value Reason
Sep-19-2020 12:27:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.2
Temperature Unit: C
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-19-2020 12:27:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-19-2020 12:27:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-19-2020 12:27:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890910
Page 142 of 250
***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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Sep-19-2020 12:27:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890911
Page 143 of 250
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-19-2020 12:27:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-19-2020 12:27:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-19-2020 12:44:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-19-2020 12:27:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-19-2020 12:27:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/19/2020Initial Entry
5.a
Date Location User Value Reason
Sep-19-2020 12:44:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPWDXWInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890912
Page 144 of 250
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a Sample ID
Date Location User Value Reason
Sep-19-2020 12:44:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPWDXWInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890913
Page 145 of 250
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-19-2020 12:28:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-19-2020 12:28:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-19-2020 12:28:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-19-2020 12:28:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/19/2020 10:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-19-2020 12:28:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-19-2020 12:28:11 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0890914
Page 146 of 250
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City of
Buenos AiresLEFT
7. Route:
Date Location User Value Reason
Sep-19-2020 12:28:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-19-2020 12:28:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-19-2020 12:28:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0890915
Page 147 of 250
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-22-2020 11:42:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0890916
Page 148 of 250
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 11:43:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 11:43:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 15:00:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 11:43:09
(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-22-2020 11:43:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020 15:00:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNTWFXInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0890917
Page 149 of 250
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 15:00:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNTWFXInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020 15:36:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNTWG0Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020 15:36:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNTWG0Initial Entry
5.c
Date Location User Value Reason
Oct-22-2020 17:52:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPW5RTInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020 17:52:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPW5RTInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890918
Page 150 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-03-2021 06:28:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed As per site
confirmation -
updated PD tracker
Mar-02-2021 10:06:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered No nasal swab,
nasal swab self or
home visit were
performed, because
the participant was
asymptomatic for
more than 4 days at
the time of
reporting
symptoms. Thank
you
Mar-02-2021 06:14:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened PDQ : Details of
Sample ID
(barcode) and
collection date for
either Nasal Swab
Self or Nasal Swab
expected to be
completed. Please
check and update
else clarify.
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Mar-01-2021 10:26:11
(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.
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0890919
Page 151 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Mar-01-2021 10:26:11
(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.
Mar-01-2021 10:26:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/22/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Mar-01-2021 10:26:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890920
Page 152 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/22/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Mar-02-2021 12:35:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/9/2021Transcription Error
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-02-2021 12:35:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resol
ved:
Jan/11/2021Transcription Error
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resol
ved:
Feb/11/2021Initial Entry
4.a
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
Symptoms: FEVERInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890921
Page 153 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires Symptom Present: NO
4.a Symptoms:
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCRE
ASED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COU
GHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890922
Page 154 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREAS
ED SHORTNESS O
F BREATH
Sympto
m Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHOR
TNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890923
Page 155 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
4.d Symptoms:
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED MUSCLE PAI
N
Sympto
m Presen
t:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUS
CLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890924
Page 156 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SORE THRO
AT
Sympto
m Presen
t:NOInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890925
Page 157 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
4.g Symptoms:
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE
THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Presen
t:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890926
Page 158 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Presen
t:YESInitial Entry
4.i Symptoms:
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Mar-01-2021 10:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
5.a
Date Location User Value Reason
Mar-01-2021 10:27:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - Other: nauseaInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Mar-01-2021 10:27:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
nauseaInitial Entry
5.b
Date Location User Value Reason
Mar-01-2021 10:28:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - Ot
her:abdominal p
ainInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890927
Page 159 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.b Symptoms - Other Text:
Date Location User Value Reason
Mar-01-2021 10:28:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
abdominal painInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890928
Page 160 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Mar-01-2021 10:29:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Mar-01-2021 10:29:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Mar-01-2021 10:29:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Mar-01-2021 10:29:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Mar-01-2021 10:29:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890929
Page 161 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Mar-01-2021 10:29:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Mar-01-2021 10:29:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Mar-01-2021 10:29:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Mar-01-2021 10:29:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890930
Page 162 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-01-2021 10:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-01-2021 10:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-01-2021 10:29:25
(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
Mar-01-2021 10:29:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
covid visit performed more tha
n 5 days after symptoms resolv
edInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890931
Page 163 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-01-2021 10:29:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-01-2021 10:29:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-01-2021 10:29:36
(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
Mar-01-2021 10:29:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
covid visit performed more tha
n 5 days after symptoms resolv
edInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890932
Page 164 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.a
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner
:SPECIA
LIST
Occurrence of Visit
s or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:EMERGENC
Y ROOM
Occurrence of
Visits or Cont
acts:YES
Number of Vi
sits or Conta
cts:
1Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890933
Page 165 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.c
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:PRIMARY C
ARE PHYSIC
IAN
Occurrence of
Visits or Cont
acts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIA
NInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890934
Page 166 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.d
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practition
er:URGENT
CARE
Occurrence of Visi
ts or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:TELEPHONE
CONSULTAT
ION
Occurrence of
Visits or Cont
acts:NOInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890935
Page 167 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIO
NInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits o
r Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890936
Page 168 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Mar-01-2021 10:30:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Has the subject been in intensi
ve care due to potential COVI
D-19 illness?
NOInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890937
Page 169 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Mar-01-2021 10:30:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890938
Page 170 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Mar-01-2021 10:30:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Mar-01-2021 10:30:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HOSPITALInitial Entry
3. Admission Date:
Date Location User Value Reason
Mar-02-2021 15:38:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-02-2021 15:10:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered subject did NOT
present any sign of
severe illness. all
information
updated. thank you
Mar-02-2021 13:42:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLIQUERY:
Hospitalization:
This subject had
COVID-19 Illness
and was
hospitalized. Please
enter any available
information (vital
signs, pulse oxymet,
respiratory
treatment, lab
results, imaging…).
Please make every
effort to obtain these
information.
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890939
Page 171 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Mar-02-2021 12:36:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/9/2021Transcription Error
Mar-01-2021 10:30:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
4. Ongoing?
Date Location User Value Reason
Mar-02-2021 12:36:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Discharge Date:
Jan/11/2021Transcription Error
Mar-01-2021 10:30:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Discharge Date:
Feb/11/2021Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890940
Page 172 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Mar-01-2021 10:31:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNES
SInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Mar-02-2021 12:37:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Diagnosi
s:
gastroenterocolitis
Date of Diagnosis:
Jan/9/2021Transcription Error
Mar-01-2021 10:31:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Diagnosi
s:
gastroenterocolitis
Date of Diagnosis:
Feb/9/2021Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Mar-01-2021 10:31:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890941
Page 173 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890942
Page 174 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-01-2021 10:34:24
(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
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sanatorio Santa Barbara, Portel
a 2975, Ciudad Autonoma de B
uenos AiresInitial Entry
3. Collection Date:
Date Location User Value Reason
Mar-02-2021 12:35:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-02-2021 12:34:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Mar-02-2021 12:34:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Collection date is
updated, but both
results and NOT
DONE is marked.
Please clarify.
Mar-02-2021 12:34:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Mar-02-2021 12:32:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Collection date is
updated, but both
results and NOT
DONE is marked.
Please clarify.
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890943
Page 175 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Mar-02-2021 12:30:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Collection Date is
before Date of First
Symptom Started
on the Signs and
Symptoms form in
the same visit.
Please review and
update as
appropriate.
Mar-02-2021 12:30:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/9/2021Transcription Error
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
4. Specimen Type:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:329
Test:: C Reactive Prot
ein_PX329
Result::
Not Done:: NOT DONE
Lab Normal Ra
nge:Initial Entry
5.a Sponsor ID:
Date Location User Value Reason
Mar-01-2021 10:34:24 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890944
Page 176 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City of
Buenos Aires(autocalc) 329
5.a Test:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
C Reactive Protein_PX329Initial Entry
5.a Not Done:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.b
Date Location User Value Reason
Mar-02-2021 12:34:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Defi
ned Identifier
:30
Test:: Alanine Aminotr
ansferase_PX30
Result:: 16
Not Done::
Lab Normal
Range:Low
4
High
40
Unit
U/LNew Information
Mar-02-2021 12:32:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Defi
ned Identifier
:30Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890945
Page 177 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Test:: Alanine Aminotr
ansferase_PX30
Result:: 16
Not Done:: NOT DONE
Lab Normal
Range:Low
4
High
40
Unit
U/L
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:30
Test:: Alanine Aminot
ransferase_PX3
0
Result::
Not Done:: NOT DONE
Lab Normal
Range:Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890946
Page 178 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.b Sponsor ID:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30Initial Entry
5.b Test:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Alanine Aminotransferase_PX3
0Initial Entry
5.b Result:
Date Location User Value Reason
Mar-02-2021 12:32:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
5.b Not Done:
Date Location User Value Reason
Mar-02-2021 12:34:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: New Information
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.b LNMT
Date Location User Value Reason
Mar-02-2021 12:32:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
4
High
40Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890947
Page 179 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Unit
U/L
5.c
Date Location User Value Reason
Mar-02-2021 12:34:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Defi
ned Identifie
r:28
Test:: Aspartate Amino
transferase_PX2
8
Result:: 19
Not Done::
Lab Normal
Range:Low
4
High
40
Unit
U/LNew Information
Mar-02-2021 12:32:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Defi
ned Identifie
r:28
Test:: Aspartate Amino
transferase_PX2
8
Result:: 19
Not Done:: NOT DONE
Lab Normal
Range:Low
4
High
40
Unit
U/LInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890948
Page 180 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:28
Test:: Aspartate Amino
transferase_PX2
8
Result::
Not Done:: NOT DONE
Lab Normal
Range:Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890949
Page 181 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.c Sponsor ID:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28Initial Entry
5.c Test:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aspartate Aminotransferase_P
X28Initial Entry
5.c Result:
Date Location User Value Reason
Mar-02-2021 12:32:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
19Initial Entry
5.c Not Done:
Date Location User Value Reason
Mar-02-2021 12:34:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: New Information
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.c LNMT
Date Location User Value Reason
Mar-02-2021 12:32:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
4
High
40Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890950
Page 182 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Unit
U/L
5.d
Date Location User Value Reason
Mar-02-2021 12:32:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Defin
ed Identifier:35
Test:: Alkaline Phosp
hatase_PX35
Result:: 216
Not Done::
Lab Normal R
ange:Low
0
High
300
Unit
U/LNew Information
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:35
Test:: Alkaline Phosp
hatase_PX35
Result:: 216
Not Done::
Lab Normal R
ange:Low
unk
High
unkInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890951
Page 183 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.d Sponsor ID:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
35Initial Entry
5.d Test:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Alkaline Phosphatase_PX35Initial Entry
5.d Result:
Date Location User Value Reason
Mar-02-2021 12:32:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Result is present,
but lab normal
range (Low, high
or Unit) is
missing. Please
correct or confirm.
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
216Initial Entry
5.d LNMT
Date Location User Value Reason
Mar-02-2021 12:32:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
0
High
300
UnitNew Information
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890952
Page 184 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
U/L
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
unk
High
unkInitial Entry
5.e
Date Location User Value Reason
Mar-02-2021 12:31:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Defined I
dentifier:21
Test:: Bilirubin_P
X21
Result:: 1.8
Not Done::
Lab Normal Rang
e:Low
0
High
1
Unit
mg/dLNew Information
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:21
Test:: Bilirubin_
PX21
Result:: 1.8
Not Done::
Lab Normal Rang
e:Low
unk
High
unkInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890953
Page 185 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.e Sponsor ID:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21Initial Entry
5.e Test:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Bilirubin_PX21Initial Entry
5.e Result:
Date Location User Value Reason
Mar-02-2021 12:31:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Result is present,
but lab normal
range (Low, high
or Unit) is
missing. Please
correct or confirm.
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1.8Initial Entry
5.e LNMT
Date Location User Value Reason
Mar-02-2021 12:31:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
0
High
1
UnitNew Information
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890954
Page 186 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
mg/dL
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
unk
High
unkInitial Entry
5.f
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:47
Test:: Blood Urea Nitr
ogen_PX47
Result::
Not Done:: NOT DONE
Lab Normal Ra
nge:Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890955
Page 187 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.f Sponsor ID:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
47Initial Entry
5.f Test:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Blood Urea Nitrogen_PX47Initial Entry
5.f Not Done:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.g
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:48
Test:: Creatinine_
PX48
Result::
Not Done:: NOT DONE
Lab Normal Range:Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890956
Page 188 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.g Sponsor ID:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
48Initial Entry
5.g Test:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Creatinine_PX48Initial Entry
5.g Not Done:
Date Location User Value Reason
Mar-01-2021 10:34:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890957
Page 189 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: 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: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890958
Page 190 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HEMATOLOGYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sanatorio Santa Barbara, Portel
a 2975, Ciudad Autonoma de B
uenos AiresInitial Entry
3. Collection Date:
Date Location User Value Reason
Mar-02-2021 14:41:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Mar-02-2021 14:40:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Collection date is
updated, but both
results and NOT
DONE is marked.
Please clarify.
Mar-01-2021 10:36:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Collection date is
updated, but both
results and NOT
DONE is marked.
Please clarify.
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890959
Page 191 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
4. Specimen Type:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Mar-02-2021 14:16:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
Sponsor-Defined
Identifier:1
Test:: Hemoglobi
n_PX1
Result:: 16.4
Not Done::
Lab Normal Ra
nge:Low
12
High
16.8
Unit
g/dLNew Information
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:1
Test:: Hemoglobi
n_PX1
Result:: 16.4
Not Done::
Lab Normal Ra
nge:Low
unk
High
unkInitial Entry
5.a Sponsor ID:
Date Location User Value Reason
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0890960
Page 192 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
5.a Test:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Hemoglobin_PX1Initial Entry
5.a Result:
Date Location User Value Reason
Mar-02-2021 14:16:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Result is present,
but lab normal
range (Low, high
or Unit) is
missing. Please
correct or confirm.
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
16.4Initial Entry
5.a LNMT
Date Location User Value Reason
Mar-02-2021 14:16:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
Low
12
High
16.8
Unit
g/dLNew Information
Mar-01-2021 10:36:27
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
LowInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890961
Page 193 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires unk
High
unk
5.b
Date Location User Value Reason
Mar-02-2021 14:15:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
Sponsor-Defined
Identifier:2
Test:: Hematocrit
_PX2
Result:: 50
Not Done::
Lab Normal Ran
ge:Low
36
High
52
Unit
%New Information
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:2
Test:: Hematocrit
_PX2
Result:: 50
Not Done::
Lab Normal Ran
ge:Low
unk
High
unkInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0890962
Page 194 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.b Sponsor ID:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
5.b Test:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Hematocrit_PX2Initial Entry
5.b Result:
Date Location User Value Reason
Mar-02-2021 14:15:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Result is present,
but lab normal
range (Low, high
or Unit) is
missing. Please
correct or confirm.
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
50Initial Entry
5.b LNMT
Date Location User Value Reason
Mar-02-2021 14:15:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
Low
36
High
52
UnitNew Information
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890963
Page 195 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
%
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
unk
High
unkInitial Entry
5.c
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:3
Test:: Erythrocytes
_PX3
Result::
Not Done:: NOT DONE
Lab Normal Range
:Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890964
Page 196 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.c Sponsor ID:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
5.c Test:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Erythrocytes_PX3Initial Entry
5.c Not Done:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.d
Date Location User Value Reason
Mar-02-2021 14:42:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
Sponsor-Defined I
dentifier:5
Test:: Platelets_
PX5
Result::
Not Done:: NOT DO
NE
Lab Normal Rang
e:Transcription Error
Mar-02-2021 14:40:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:5
Test:: Platelets_
PX5
Result::Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890965
Page 197 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Not Done:: NOT DO
NE
Lab Normal Rang
e:Low
unk
High
unk
Mar-02-2021 14:24:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:
Test:: Platelets_
PX5
Result::
Not Done::
Lab Normal Rang
e:Low
unk
High
unkTranscription Error
Mar-01-2021 10:36:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Defined I
dentifier:5
Test:: Platelets_
PX5
Result:: 23300
Not Done::
Lab Normal Rang
e:Low
unk
High
unkTranscription Error
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:5
Test:: Platelets_
PX5
Result:: 23300
Not Done:: NOT DO
NEInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890966
Page 198 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Lab Normal Rang
e:Low
unk
High
unk
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890967
Page 199 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.d Sponsor ID:
Date Location User Value Reason
Mar-02-2021 14:40:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
Mar-02-2021 14:24:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
5.d Test:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Platelets_PX5Initial Entry
5.d Result:
Date Location User Value Reason
Mar-02-2021 14:24:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-02-2021 14:24:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry: Transcription Error
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Result is present,
but lab normal
range (Low, high or
Unit) is missing.
Please correct or
confirm.
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
23300Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890968
Page 200 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.d Not Done:
Date Location User Value Reason
Mar-02-2021 14:40:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
NOT DONEInitial Entry
Mar-01-2021 10:36:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.d LNMT
Date Location User Value Reason
Mar-02-2021 14:42:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry: Transcription Error
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
unk
High
unkInitial Entry
5.e
Date Location User Value Reason
Mar-02-2021 14:41:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
Sponsor-Defined
Identifier:7
Test:: Leukocyte
s_PX7
Result:: 23.3
Not Done::Transcription Error
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890969
Page 201 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Lab Normal Ran
ge:Low
4
High
10
Unit
10^9/L
Mar-02-2021 14:40:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
Sponsor-Defined
Identifier:7
Test:: Leukocyte
s_PX7
Result:: 23.3
Not Done:: NOT DON
E
Lab Normal Ran
ge:Low
4
High
10
Unit
10^9/LInitial Entry
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:7
Test:: Leukocyte
s_PX7
Result::
Not Done:: NOT DO
NE
Lab Normal Ran
ge:Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0890970
Page 202 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.e Sponsor ID:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
5.e Test:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Leukocytes_PX7Initial Entry
5.e Result:
Date Location User Value Reason
Mar-02-2021 14:40:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
23.3Initial Entry
5.e Not Done:
Date Location User Value Reason
Mar-02-2021 14:41:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry: Transcription Error
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.e LNMT
Date Location User Value Reason
Mar-02-2021 14:40:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
Low
4
High
10Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890971
Page 203 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Unit
10^9/L
5.f
Date Location User Value Reason
Mar-02-2021 14:19:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
Sponsor-Define
d Identifier:608
Test:: Neutrophils
_PX608
Result:: 87
Not Done::
Lab Normal Ra
nge:Low
50
High
70
Unit
%New Information
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0890972
Page 204 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
5.f
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:608
Test:: Neutrophils_
PX608
Result:: 87
Not Done::
Lab Normal Rang
e:Low
unk
High
unkInitial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0890973
Page 205 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.f Sponsor ID:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
608Initial Entry
5.f Test:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Neutrophils_PX608Initial Entry
5.f Result:
Date Location User ValueReason
Mar-08-2021
03:03:55
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies
query
Mar-05-2021
16:05:25
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
2: An
swere
dAn attempt was made
in multiple ways to
obtain the absolute
leukocyte formula
values, even speaking
to the head of the
Sanatorio Santa
Barbara laboratory,
not being possible
since they do not
report the results in
this way in the
laboratory
Mar-04-2021
15:39:44
(UTC-03:00)
City of
BuenosACV0PFEINFP6000  Query
2: Rei
ssued:
Opene
dWBC differentials
should be reported in
absolute values.
please update
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0890974
Page 206 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aires
Mar-04-2021
10:16:52
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
2: An
swere
dAbsolute values are
not available for
differentials entered
as percentages. thank
you.
Mar-03-2021
12:22:52
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Op
enedDMW7565093;Please
confirm that the
WBC differentials are
entered as absolute
values instead of
percentages, or
correct as
appropriate.
Mar-02-2021
14:19:39
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query
1: Clo
sedClose Auto Query
Mar-01-2021
10:36:27
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query
1: Op
enedResult is present, but
lab normal range
(Low, high or Unit) is
missing. Please
correct or confirm.
Mar-01-2021
10:36:27
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
87Initial Entry
5.f LNMT
Date Location User Value Reason
Mar-02-2021 14:19:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
Low
50New Information
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0890975
Page 207 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
High
70
Unit
%
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
unk
High
unkInitial Entry
5.g
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:609
Test:: Eosinophils_
PX609
Result::
Not Done:: NOT DONE
Lab Normal Rang
e:Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890976
Page 208 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.g Sponsor ID:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
609Initial Entry
5.g Test:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Eosinophils_PX609Initial Entry
5.g Not Done:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.h
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:612
Test:: Monocytes_
PX612
Result::
Not Done:: NOT DONE
Lab Normal Rang
e:Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890977
Page 209 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.h Sponsor ID:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
612Initial Entry
5.h Test:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Monocytes_PX612Initial Entry
5.h Not Done:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.i
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:610
Test:: Basophils_P
X610
Result::
Not Done:: NOT DONE
Lab Normal Range
:Initial Entry
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890978
Page 210 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315622 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.i Sponsor ID:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
610Initial Entry
5.i Test:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Basophils_PX610Initial Entry
5.i Not Done:
Date Location User Value Reason
Mar-01-2021 10:36:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.j
Date Location User Value Reason
Mar-01-2021 10:36:27
(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
090177e196ae2e59\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0890979
Page 211 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/22/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
A
…[truncated]