Document text
Page 1 of 253
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version08 SEP 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005163
Page 2 of 253
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/23/2020
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005164
Page 3 of 253
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Demography
1.Subject ID [44441748]
2.Birth Date: /1969
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005165
Page 4 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005166
Page 5 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005167
Page 6 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/23/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005168
Page 7 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Arterial hypertension]
Start Date: Sep/3/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Anxiety disorder]
Start Date: Sep/7/2017
Ongoing: YES
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005169
Page 8 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005170
Page 9 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
2.Weight: [61.0]
3.Unit: kg
4.Height: [159.0]
5.Unit: cm
6.Body Mass Index: [24.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005171
Page 10 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/23/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005172
Page 11 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/23/2020
2.Randomization Number: [98137]
3.Randomization Group: [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005173
Page 12 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
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 [BPXHYH]
5.bSample ID [BRVLSY]
5.cSample ID [BRVLSJ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005174
Page 13 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
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 [BP1XV7]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005175
Page 14 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/23/2020 17:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005176
Page 15 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005177
Page 16 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005178
Page 17 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Oct/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005179
Page 18 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/14/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005180
Page 19 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
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 [BPXK2W]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005181
Page 20 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/14/2020 15:42
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005182
Page 21 of 253
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005183
Page 22 of 253
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/12/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNV104]
5.bSample ID [BNV0Z0]
5.cSample ID [BP1R3R]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005184
Page 23 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/16/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005185
Page 24 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/16/2021
2.Date of First Symptom
Started:Jan/13/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/17/2021
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? YES
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005186
Page 25 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Abdominal pain]
5.bSymptoms - Other Text: [Headache]
5.cSymptoms - Other Text: [Sickness]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005187
Page 26 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
1.Jan/16/
2021 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005188
Page 27 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/16/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASOPHARYNX
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005189
Page 28 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[Sample collected by team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005190
Page 29 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/16/2021
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 [BPTC2K]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005191
Page 30 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005192
Page 31 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?NO
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005193
Page 32 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005194
Page 33 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005195
Page 34 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?YES
Respiratory Illness Diagnosis:
[Flu syndrome]
Date of Diagnosis:
Jan/16/2021
3.Toxicity Grade: 1
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005196
Page 35 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1. Repeating
Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005197
Page 36 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005198
Page 37 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1. Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005199
Page 38 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005200
Page 39 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
1. Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005201
Page 40 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005202
Page 41 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005203
Page 42 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005204
Page 43 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005205
Page 44 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005206
Page 45 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1. Repeating
Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005207
Page 46 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005208
Page 47 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005209
Page 48 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005210
Page 49 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1. Repeating
Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005211
Page 50 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005212
Page 51 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/17/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005213
Page 52 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/17/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/17/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRM8T0]
5.bSample ID [BS1RSD]
5.cSample ID [BS1RRR]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005214
Page 53 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005215
Page 54 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005216
Page 55 of 253
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005217
Page 56 of 253
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Unplanned Assessments
1.Assessments
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005218
Page 57 of 253
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 esophageal impac
tion with food Sep/28/20
20 21:00 NO
End Date Time:
Sep/29/2020 10:3
0
Repeating
Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005219
Page 58 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[esophageal impaction with food]
4.Start Date Time: Sep/28/2020 21:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/29/2020 10:30
6.Toxicity Grade: 3
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005220
Page 59 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[food impaction]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005221
Page 60 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
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[2020378726]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005222
Page 61 of 253
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005223
Page 62 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005224
Page 63 of 253
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005225
Page 64 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005226
Page 65 of 253
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005227
Page 66 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005228
Page 67 of 253
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005229
Page 68 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005230
Page 69 of 253
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005231
Page 70 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005232
Page 71 of 253
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005233
Page 72 of 253
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005234
Page 73 of 253
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005235
Page 74 of 253
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005236
Page 75 of 253
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005237
Page 76 of 253
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005238
Page 77 of 253
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005239
Page 78 of 253
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005240
Page 79 of 253
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/9/2021
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005241
Page 80 of 253
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/9/2021
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 [BR1W7J]
5.bSample ID [BNTZBY]
5.cSample ID [BRT8GW]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005242
Page 81 of 253
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/9/2021
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 [BR1W4X]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005243
Page 82 of 253
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005244
Page 83 of 253
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/19/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005245
Page 84 of 253
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/19/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/19/2021
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 [BR1MRX]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005246
Page 85 of 253
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/03/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK4
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005247
Page 86 of 253
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/03/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
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 [BP1ZCC]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005248
Page 87 of 253
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005249
Page 88 of 253
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005250
Page 89 of 253
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/3/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005251
Page 90 of 253
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005252
Page 91 of 253
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005253
Page 92 of 253
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/6/2021
2.Erroneous Visit
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005254
Page 93 of 253
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/6/2021
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005255
Page 94 of 253
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005256
Page 95 of 253
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Mar/6/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005257
Page 96 of 253
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/6/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005258
Page 97 of 253
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/6/2021
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 [BNTST6]
5.bSample ID [BR23GL]
5.cSample ID [BNTSV0]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005259
Page 98 of 253
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/6/2021
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 [BR209G]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005260
Page 99 of 253
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/6/2021 14:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005261
Page 100 of 253
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005262
Page 101 of 253
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005263
Page 102 of 253
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005264
Page 103 of 253
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005265
Page 104 of 253
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005266
Page 105 of 253
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005267
Page 106 of 253
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005268
Page 107 of 253
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005269
Page 108 of 253
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005270
Page 109 of 253
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005271
Page 110 of 253
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005272
Page 111 of 253
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/12/2020
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005273
Page 112 of 253
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005274
Page 113 of 253
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005275
Page 114 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-23-2020 19:09:34 (UTC-03:00)
City of Buenos AiresMartina
DavalliNot Applicable
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005276
Page 115 of 253
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormMar-08-2021 11:13:58 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005277
Page 116 of 253
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Agustin
Morato
Cabral N/A Mar-05-2021 08:28:45 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-04-2021 16:00:40 (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.
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005278
Page 117 of 253
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Alan
Colombo N/A Feb-24-2021 11:24:23 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-22-2021 10:23:23 (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.
Agustin
Morato
Cabral N/A Feb-20-2021 16:41:12 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Yanina
Rivera Approved Feb-19-2021 16:00:07 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005279
Page 118 of 253
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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-18-2021 09:48:01 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Yanina
Rivera Approved Feb-17-2021 23:02:16 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005280
Page 119 of 253
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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-17-2021 14:15:37 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-16-2021 11:51:17 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005281
Page 120 of 253
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Feb-09-2021 14:16:54 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Gonzalo
Perez Marc Approved Jan-22-2021 16:02:21 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005282
Page 121 of 253
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, GonzaloPerez, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Jan-22-2021 13:43:29 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-22-2021 08:25:12 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005283
Page 122 of 253
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Jan-17-2021 19:19:06 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-27-2020 19:46:17 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005284
Page 123 of 253
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Nov-27-2020 13:46:16 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-13-2020 18:38:06 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005285
Page 124 of 253
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Nov-12-2020 17:57:51 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-10-2020 11:11:28 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005286
Page 125 of 253
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, verify that all case report form pages
accurately display the results of the examinations, tests, evaluations and treatments performed on
this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005287
Page 126 of 253
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-23-2020
19:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-23-2020
19:07:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005288
Page 127 of 253
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-23-2020
19:08:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/23/2020Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005289
Page 128 of 253
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-02-2020
08:47:12
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Cl
osedEvent entered in Inform
Oct-01-2020
07:52:10
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Op
enedSAE
RECON:AER#2020378726
Esophageal food
impaction(onset
date:28Sep2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Sep-23-2020
16:55:41
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
44441748Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-23-2020 ACV0PFEINFP6000 auto calc Data Entry: Enrollment
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1005290
Page 129 of 253
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
16:55:38
(UTC-03:00) City
of Buenos Aires(autocalc) /1969 Entry
3. Sex:
Date Location User Value Reason
Sep-23-2020
19:09:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-23-2020
19:09:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
HISPANIC OR LAT
INO(A) OR OF SPA
NISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-23-2020
19:09:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
WHITEInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005291
Page 130 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-23-2020
19:09:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sep/23/2020Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005292
Page 131 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-23-2020
19:09:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sep/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-23-2020
19:09:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-23-2020
19:09:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
COMPLETEDInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005293
Page 132 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Sep-23-2020
19:10:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:Arterial h
ypertensi
on
Start Date: Sep/3/201
4
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-23-2020
19:10:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020
19:10:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Arterial hypertensionInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005294
Page 133 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.a Start Date:
Date Location User Value Reason
Sep-23-2020
19:10:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sep/3/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-23-2020
19:10:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Nov-27-2020
13:46:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:Anxiety
disorder
Start Date
:Sep/7/2
017
Ongoing: YESNew
Information
Sep-23-2020
19:11:03ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH 2Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005295
Page 134 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresNumber:
Medical H
istory Ter
m:Anxiety
disorder
Start Date
:Sep/14/
2017
Ongoing: YES
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005296
Page 135 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.b Line/MH Number:
Date Location User Value Reason
Sep-23-2020
19:11:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020
19:11:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Anxiety disorderInitial Entry
1.b Start Date:
Date Location User Value Reason
Nov-27-2020
13:58:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Juleen Gayed Query 1: Closed Response
satisfies query
Nov-27-2020
13:46:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New
Information
Nov-27-2020
13:46:16
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
Sep/7/2017New
Information
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005297
Page 136 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires
Nov-27-2020
11:44:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Juleen Gayed Query 1: Opened Clin: Please
confirm this
start date as
start date for
clonazepam
documented in
SAE report for
management
of anxiety is
07/Sep/2017
which is before
this start date
Sep-23-2020
19:11:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sep/14/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-23-2020
19:11:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005298
Page 137 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-23-2020
19:11:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
The subject is NOT
known to be HIV PO
SITIVEInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005299
Page 138 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020
19:13:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sep/23/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-23-2020
19:13:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
61.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-23-2020
19:13:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-23-2020 ACV0PFEINFP6000 Martina Data Entry: Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005300
Page 139 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
19:13:19
(UTC-03:00) City
of Buenos AiresDavalli 159.0
5. Unit:
Date Location User Value Reason
Sep-23-2020
19:13:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-23-2020
19:13:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24.1Initial Entry
7.a
Date Location User Value Reason
Sep-23-2020
19:13:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Record Ide
ntifier::1
Temperatu
re:36.6
Temperatu
re Unit:CInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005301
Page 140 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-23-2020
19:13:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-23-2020
19:13:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-23-2020
19:13:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005302
Page 141 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-23-2020
19:13:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
ORAL CAVITYInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005303
Page 142 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-23-2020
19:13:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-23-2020
19:13:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-23-2020
19:13:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sep/23/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-23-2020 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005304
Page 143 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
19:13:28
(UTC-03:00) City
of Buenos Aires(autocalc) STUDY SITE
5. Specimen Type:
Date Location User Value Reason
Sep-23-2020
19:13:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-23-2020
19:13:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005305
Page 144 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-23-2020
19:13:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-23-2020
19:13:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-23-2020
19:13:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NEGATIVEInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005306
Page 145 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-23-2020
19:13:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sep/23/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-23-2020
19:13:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
98137Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005307
Page 146 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020
19:13:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020
19:13:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020
14:35:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-24-2020
06:24:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005308
Page 147 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Sep-23-2020
19:13:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-23-2020
19:13:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection
:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020
14:35:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPXHY
HInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020
14:35:45ACV0PFEINFP6000 Data Entry:
BPXHYHInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005309
Page 148 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
5.b
Date Location User Value Reason
Sep-24-2020
15:26:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BRVLS
YInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-24-2020
15:26:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BRVLSYInitial Entry
5.c
Date Location User Value Reason
Sep-24-2020
15:31:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BRVLS
JInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005310
Page 149 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.c Sample ID
Date Location User Value Reason
Sep-24-2020
15:31:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BRVLSJInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005311
Page 150 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020
19:13:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020
19:13:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020
10:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-24-2020
06:24:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005312
Page 151 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Sep-23-2020
19:13:47
(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.
Sep-23-2020
19:13:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection
:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020
10:56:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BP1XV
7Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020
10:56:35ACV0PFEINFP6000 Data Entry:
BP1XV7Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005313
Page 152 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005314
Page 153 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-23-2020
19:14:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020
19:14:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020
19:14:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-23-2020
19:14:04ACV0PFEINFP6000 Martina
DavalliData Entry:
Sep/23/2020 17:26Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005315
Page 154 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020
19:14:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-23-2020
19:14:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-23-2020
19:14:04
(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-23-2020
19:14:04ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005316
Page 155 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-23-2020
19:14:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005317
Page 156 of 253
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-23-2020
19:14:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005318
Page 157 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020
11:40:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005319
Page 158 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Oct-15-2020
11:40:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
2.a
Date Location User Value Reason
Oct-15-2020
11:40:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Id
entifier::1
Temperat
ure:36.3
Temperat
ure Unit:C
Temperat
ure Locat
ion::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-15-2020
11:40:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005320
Page 159 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
2.a Temperature:
Date Location User Value Reason
Oct-15-2020
11:40:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
36.3Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-15-2020
11:40:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-15-2020
11:40:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005321
Page 160 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-15-2020
11:41:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-15-2020
11:41:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-15-2020
11:41:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-15-2020 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005322
Page 161 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
11:41:02
(UTC-03:00) City
of Buenos Aires(autocalc) STUDY SITE
5. Specimen Type:
Date Location User Value Reason
Oct-15-2020
11:41:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-15-2020
11:41:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005323
Page 162 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-15-2020
11:41:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-15-2020
11:41:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropi
n Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-15-2020
11:41:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005324
Page 163 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020
10:03:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020
10:03:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
10:04:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-15-2020
10:03:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005325
Page 164 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Oct-15-2020
10:03:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020
10:04:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample I
D:BPXK2
WInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020
10:04:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BPXK2WInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005326
Page 165 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-15-2020
11:41:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-15-2020
11:41:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-15-2020
11:41:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-15-2020
11:41:48ACV0PFEINFP6000 Data Entry:
Oct/14/2020 15:42Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005327
Page 166 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Oct-15-2020
11:41:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-15-2020
11:41:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-15-2020
11:41:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-15-2020
11:41:48ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005328
Page 167 of 253
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-15-2020
11:41:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005329
Page 168 of 253
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-12-2020
17:57:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/12/2020Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005330
Page 169 of 253
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-12-2020
17:58:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020
17:58:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020
10:37:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-12-2020
20:08:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005331
Page 170 of 253
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Nov-12-2020
17:58:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-12-2020
17:58:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020
10:37:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BNV10
4Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-13-2020
10:37:34
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
BNV104Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005332
Page 171 of 253
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires
5.b
Date Location User Value Reason
Nov-13-2020
10:47:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Sample I
D:BNV0Z
0Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-13-2020
10:47:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
BNV0Z0Initial Entry
5.c
Date Location User Value Reason
Nov-13-2020
11:43:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BP1R3
RInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005333
Page 172 of 253
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.c Sample ID
Date Location User Value Reason
Nov-13-2020
11:43:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BP1R3RInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005334
Page 173 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-17-2021
19:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Jan-17-2021
19:19:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms
form is
missing. Please
review and
update as
appropriate.
Jan-17-2021
19:19:05
(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
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005335
Page 174 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nasal Swab
are missing.
Please review
and update as
appropriate.
Jan-17-2021
19:19:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/16/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-17-2021
19:19:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005336
Page 175 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/16/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/13/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-22-2021
13:43:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
Date of Last Sympt
om Resolved:
Jan/17/2021New
Information
Jan-17-2021
19:20:30
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005337
Page 176 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires
4.a
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: FEVE
R
Symptom Pre
sent:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005338
Page 177 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED
COUGH
Sympt
om Pre
sent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASE
D COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symp
toms:NEW OR INC
REASED SH
ORTNESS OFInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005339
Page 178 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
BREATH
Symp
tom P
resen
t:NO
4.c Symptoms:
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASE
D SHORTNESS OF B
REATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: CHIL
LS
Symptom Pre
sent:NOInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005340
Page 179 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.d Symptoms:
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE PA
IN
Sympt
om Pr
esent:YESInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005341
Page 180 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.e Symptoms:
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASE
D MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pre
sent:NOInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005342
Page 181 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.f Symptoms:
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW LOSS OF TAS
TE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THROA
T
Sympt
om Pr
esent:YESInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005343
Page 182 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.g Symptoms:
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASE
D SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: DIARR
HEA
Symptom P
resent:NOInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005344
Page 183 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.h Symptoms:
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: VOMIT
ING
Symptom P
resent:NOInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005345
Page 184 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4.i Symptoms:
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-17-2021
19:20:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Jan-17-2021
19:21:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms
- Other:Abdomin
al painInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Jan-17-2021
19:21:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Abdominal painInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005346
Page 185 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.b
Date Location User Value Reason
Jan-17-2021
19:21:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms -
Other:Heada
cheInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Jan-17-2021
19:21:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
HeadacheInitial Entry
5.c
Date Location User Value Reason
Jan-17-2021
19:21:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms -
Other:Sickn
essInitial Entry
5.c Symptoms - Other Text:
Date Location User Value Reason
Jan-17-2021
19:21:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
SicknessInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005347
Page 186 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Jan-17-2021
19:22:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005348
Page 187 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Jan-17-2021
19:22:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/16/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-17-2021
19:22:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERI
ALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-17-2021
19:22:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Jan-17-2021
19:22:30ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005349
Page 188 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresP SYNDROME CORO
NAVIRUS 2
5. Device Type:
Date Location User Value Reason
Jan-17-2021
19:22:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGN
OSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Jan-17-2021
19:22:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ATILA BIOSYSTEM
S IAMP COVID-19 D
ETECTION KITInitial Entry
7. Test Result:
Date Location User Value Reason
Jan-17-2021
19:22:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005350
Page 189 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-17-2021
19:23:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-17-2021
19:23:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-17-2021
19:23:27
(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
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005351
Page 190 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Jan-17-2021
19:23:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample collected by te
am physicianInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005352
Page 191 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-17-2021
19:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-17-2021
19:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-18-2021
10:35:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-18-2021
08:45:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005353
Page 192 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Jan-17-2021
19:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-17-2021
19:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/16/2021Initial Entry
5.a
Date Location User Value Reason
Jan-18-2021
10:35:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPTC2
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-18-2021
10:35:09
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
BPTC2KInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005354
Page 193 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005355
Page 194 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Pract
itioner:SPEC
IALIS
T
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005356
Page 195 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Pr
actitioner:EMERG
ENCY
ROOM
Occurrenc
e of Visits o
r Contacts:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Jan-17-2021
19:23:52ACV0PFEINFP6000 Data Entry:
Type of P PRIMARInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1005357
Page 196 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Airesractitione
r:Y CARE
PHYSICI
AN
Occurren
ce of Visit
s or Cont
acts:NO
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
PRIMARY CARE PH
YSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Prac
titioner:URGE
NT C
AREInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1005358
Page 197 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Occurrence
of Visits or
Contacts:NO
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of P
ractitione
r:TELEPH
ONE CO
NSULTA
TIONInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005359
Page 198 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Occurren
ce of Visit
s or Cont
acts:NO
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
TELEPHONE CONS
ULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:OT
HE
R
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005360
Page 199 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Jan-17-2021
19:23:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005361
Page 200 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/16/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Jan-17-2021
19:24:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-
19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Jan-17-2021
19:24:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness
Diagnosis:
Flu syndrome
Date of Diagnosis:
Jan/16/2021Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Jan-17-2021
19:24:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005362
Page 201 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/17/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-17-2021
14:15:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/17/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-17-2021
14:15:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005363
Page 202 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/17/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-17-2021
14:15:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-17-2021
14:15:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-18-2021
09:48:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-18-2021
09:43:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005364
Page 203 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/17/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Feb-17-2021
14:15:46
(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.
Feb-17-2021
14:15:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/17/2021Initial Entry
5.a
Date Location User Value Reason
Feb-18-2021
09:48:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BRM8
T0Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-18-2021
09:48:01
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
BRM8T0Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005365
Page 204 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/17/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires
5.b
Date Location User Value Reason
Feb-18-2021
15:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample I
D:BS1RS
DInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-18-2021
15:42:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BS1RSDInitial Entry
5.c
Date Location User Value Reason
Feb-18-2021
15:50:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BS1RR
RInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005366
Page 205 of 253
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/17/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
5.c Sample ID
Date Location User Value Reason
Feb-18-2021
15:50:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BS1RRRInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005367
Page 206 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Oct-01-2020
12:56:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005368
Page 207 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Oct-01-2020
12:56:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-01-2020
12:56:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-07-2020
17:05:08
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Samuel
DychterQuery 2: Closed GPD Clin:
Will review
SAE narrative
for the
information.
Oct-07-2020
17:04:41
(UTC-03:00)
City of BuenosACV0PFEINFP6000 Samuel
DychterQuery 1: Closed Response
satisfies query
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005369
Page 208 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Aires
Oct-05-2020
17:01:21
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Answere
dAccording to
the
investigator in
charge, the
subject in
question does
not have any
medical
history of
esophageal
disease. Thank
you.
Oct-01-2020
18:33:51
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Samuel
DychterQuery 2: Opened GPD Clin:
Please clarify
the clinical
course of this
event.
Oct-01-2020
18:33:05
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Samuel
DychterQuery 1: Opened GPD Clin:
Please confirm
if the subject
has a medical
history of
esophageal
issues.
Oct-01-2020
12:56:45
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
esophageal impacti
on with foodInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005370
Page 209 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
4. Start Date Time:
Date Location User Value Reason
Oct-01-2020
12:57:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-01-2020
12:57:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/28/2020 21:00Transcription
Error
Oct-01-2020
12:56:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For esophageal
impaction with
food Start Date
28/Oct/2020, is
a future date
relative to
when it was
entered on
01/Oct/2020.
Please correct.
Oct-01-2020
12:56:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/28/2020 21:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-23-2020 ACV0PFEINFP6000 Query 2: Closed 10:30 AM on
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005371
Page 210 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
14:57:27
(UTC-03:00)
City of Buenos
Aires9/29/20
clarified as ER
discharge time;
therefore
endoscopy is
appropriately
earlier on
9/29/20
Oct-09-2020
17:54:43
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 2: Reissue
d:OpenedCLINICAL
Thank you for
confirming
event end time
on Sep 29 of
10:30 AM.
Please submit
this time in a
SAE safety
update, as it
was not
submitted in
the original
SAE report
Oct-08-2020
20:54:31
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 2: Answer
edAccording to
HC, the EA
began on
28Sep2020 at
9:00 p.m.
having ended
on 29Sep2020
at 10.30 am.
Oct-05-2020 ACV0PFEINFP6000 Query 2: Opened CLINICAL
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005372
Page 211 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
16:32:33
(UTC-03:00)
City of Buenos
AiresEnd time of
AE is 10:30 on
29 Sep 2020;
however, SAE
end time is
00:00 (default
time for
missing data)
on 29 Sep
2020. Please
submit a safety
update to
include the end
time of SAE.
Oct-05-2020
13:55:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 2: Candid
ateCLINICAL
End time of
AE is 10:30 on
29 Sep 2020;
however, SAE
end time is
00:00 (default
time for
missing data)
on 29 Sep
2020. Please
submit a safety
update to
include the end
time of SAE.
Oct-01-2020
12:57:19
(UTC-03:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005373
Page 212 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
City of Buenos
Aires
Oct-01-2020
12:57:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time
:
Sep/29/2020
10:30Transcription
Error
Oct-01-2020
12:56:45
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For esophageal
impaction with
food End Date
29/Oct/2020,
is a future date
relative to
when it was
entered on
01/Oct/2020.
Please correct.
Oct-01-2020
12:56:45
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time
:
Oct/29/2020
10:30Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005374
Page 213 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-01-2020
12:56:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-02-2020
08:45:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-01-2020
12:56:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
esophageal
impaction with
food:
Response to
"Is the adverse
event
serious?" is
'Yes' but
"Serious
Adverse Event
Number" is
blank.
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005375
Page 214 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-01-2020
12:56:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event
associated with con
genital anomaly or
birth defect?
NO
Did this serious eve
nt result in death?
NO
Did this serious eve
nt require or prolon
g hospitalization?
NO
Did this serious eve
nt result in persisten
t or significant disab
ility/incapacity?
NO
Is this serious event
life threatening?
NO
Other medically imInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005376
Page 215 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
portant serious even
t
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-01-2020
12:56:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-01-2020
12:56:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this ev
ent is due to:
OTHER
If Other, specify:
food impactionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005377
Page 216 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-01-2020
12:56:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-01-2020
12:56:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-01-2020
15:35:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESNew
Information
Oct-01-2020
12:56:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-01-2020
12:56:45
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (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-2021-5683-1005378
Page 217 of 253
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-01-2020
12:56:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-02-2020
08:45:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
2020378726Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005379
Page 218 of 253
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-12-2020
17:58:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-12-2020
17:58:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-12-2020
17:58:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005380
Page 219 of 253
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-09-2021
14:16:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/9/2021Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005381
Page 220 of 253
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-09-2021
14:17:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Feb/9/2021Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005382
Page 221 of 253
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-09-2021
14:17:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-09-2021
14:17:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-24-2021
16:32:34
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Feb-24-2021
11:24:34
(UTC-03:00)
City of BuenosACV0PFEINFP6000 Alan Colombo Query 2: Answere
dOriginal value
is correct
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005383
Page 222 of 253
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Aires
Feb-23-2021
18:10:52
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 2: Opened Barcode
BRT8GW
received at
laboratory for
this subject.
Please,
confirm it and
update Inform
if applicable.
Thanks
Feb-10-2021
12:14:13
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-10-2021
01:54:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-09-2021
14:17:13
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005384
Page 223 of 253
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
and correct as
appropriate.
Feb-09-2021
14:17:13
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Feb/9/2021Initial Entry
5.a
Date Location User Value Reason
Feb-10-2021
12:14:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BR1W7
JInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-10-2021
12:14:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BR1W7JInitial Entry
5.b
Date Location User Value Reason
Feb-10-2021
13:01:34
(UTC-03:00) CityACV0PFEINFP6000 Azul Mozzi Data Entry:
Sample ID BNTZBInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005385
Page 224 of 253
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires : Y
5.b Sample ID
Date Location User Value Reason
Feb-10-2021
13:01:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Azul Mozzi Data Entry:
BNTZBYInitial Entry
5.c
Date Location User Value Reason
Feb-24-2021
11:24:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample I
D:BRT8G
WInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-24-2021
11:24:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BRT8GWInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005386
Page 225 of 253
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-09-2021
16:12:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-09-2021
16:12:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021
12:17:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-10-2021
01:54:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005387
Page 226 of 253
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Feb-09-2021
16:12:35
(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.
Feb-09-2021
16:12:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/9/2021Initial Entry
5.a
Date Location User Value Reason
Feb-10-2021
12:17:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BR1W4
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-10-2021
12:17:58
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
BR1W4XInitial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005388
Page 227 of 253
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005389
Page 228 of 253
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/19/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441748 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-20-2021
16:41:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Feb/19/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-20-2021
16:41:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
SSWAB_WEEK2Initial Entry
090177e196ae2f14\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005390
Page 229 of 253
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/19/202
…[truncated]