Document text
Page 1 of 189
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883911
Page 2 of 189
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/27/2020
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883912
Page 3 of 189
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Demography
1.Subject ID [12314465]
2.Birth Date: /1954
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883913
Page 4 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883914
Page 5 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883915
Page 6 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883916
Page 7 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Erectile dysfunction]
Start Date: Aug/1/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type 2 diabetes]
Start Date: Apr/1/2014
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Prostate cancer]
Start Date: Oct/1/2018
Ongoing: NO
End Date:
Jun/1/2019
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Radical Prostatectomy]
Start Date: Dec/1/2018
Ongoing: NO
End Date:
Dec/15/2018
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883917
Page 8 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [74.4]
3.Unit: kg
4.Height: [176.0]
5.Unit: cm
6.Body Mass Index: [24.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883918
Page 9 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [242957]
3.Randomization Group: [ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883919
Page 10 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTFZB]
5.bSample ID [BPTFZC]
5.cSample ID [BPTFZD]
5.dSample ID [BLBJ9H]
5.eSample ID [BLBJ9J]
5 fSample ID [BLBJ9K]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883920
Page 11 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTFHC]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883921
Page 12 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/27/2020 12:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883922
Page 13 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883923
Page 14 of 189
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883924
Page 15 of 189
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883925
Page 16 of 189
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1RD9]
5.bSample ID [BP1RCB]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883926
Page 17 of 189
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/15/2020 14:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883927
Page 18 of 189
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883928
Page 19 of 189
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1PGS]
5.bSample ID [BLBKF6]
5.cSample ID [BLBKFM]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883929
Page 20 of 189
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883930
Page 21 of 189
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883931
Page 22 of 189
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883932
Page 23 of 189
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883933
Page 24 of 189
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883934
Page 25 of 189
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883935
Page 26 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/27/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883936
Page 27 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/27/2020
2.Date of First Symptom Started: Sep/25/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/29/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
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? YES
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883937
Page 28 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [FATIGUE]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883938
Page 29 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1.Sep/27/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883939
Page 30 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/27/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883940
Page 31 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[SAMPLE COLLECT BY TEAM PHYSICIAN]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883941
Page 32 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/27/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWSKC]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883942
Page 33 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883943
Page 34 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883944
Page 35 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatme
ntTreatme
ntStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883945
Page 36 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883946
Page 37 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883947
Page 38 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category of Clinical Eve
nt:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883948
Page 39 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883949
Page 40 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883950
Page 41 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883951
Page 42 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883952
Page 43 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883953
Page 44 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883954
Page 45 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883955
Page 46 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883956
Page 47 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883957
Page 48 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883958
Page 49 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883959
Page 50 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883960
Page 51 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883961
Page 52 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883962
Page 53 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883963
Page 54 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/29/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883964
Page 55 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/29/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BJ4DC2]
5.bSample ID [BJ4DCH]
5.cSample ID [BPW5Z5]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883965
Page 56 of 189
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883966
Page 57 of 189
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unplanned Assessments
1.Assessments
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883967
Page 58 of 189
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883968
Page 59 of 189
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883969
Page 60 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883970
Page 61 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883971
Page 62 of 189
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883972
Page 63 of 189
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883973
Page 64 of 189
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883974
Page 65 of 189
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883975
Page 66 of 189
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883976
Page 67 of 189
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883977
Page 68 of 189
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: Not Applicable Comments
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883978
Page 69 of 189
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883979
Page 70 of 189
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883980
Page 71 of 189
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883981
Page 72 of 189
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination
1/2
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883982
Page 73 of 189
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#CategoryAE Identifi
erAdverse Eve
ntStart DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 Penile infecti
on Jan/22/2021 10:
00 YES Repeating
Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883983
Page 74 of 189
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Penile infection]
4.Start Date Time: Jan/22/2021 10:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883984
Page 75 of 189
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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:
[Erectile dysfunction surgery]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021313544]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883985
Page 76 of 189
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883986
Page 77 of 189
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883987
Page 78 of 189
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883988
Page 79 of 189
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883989
Page 80 of 189
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883990
Page 81 of 189
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883991
Page 82 of 189
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883992
Page 83 of 189
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883993
Page 84 of 189
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883994
Page 85 of 189
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883995
Page 86 of 189
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883996
Page 87 of 189
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Booster Dose Trigger Form
1.Select appropriate response - Will
the participant return for
consent/eligibility assessment for
the booster dose visit?
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883997
Page 88 of 189
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/10/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883998
Page 89 of 189
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883999
Page 90 of 189
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884000
Page 91 of 189
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/19/2020
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884001
Page 92 of 189
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884002
Page 93 of 189
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-24-2021 16:59:21 (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.
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884003
Page 94 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-27-2020 15:22:43 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884004
Page 95 of 189
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - Comments
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormFeb-10-2021 12:31:48 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884005
Page 96 of 189
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT Form: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - Comments
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
1Feb-10-2021 12:31:48 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884006
Page 97 of 189
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormFeb-10-2021 12:32:06 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884007
Page 98 of 189
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
1Feb-10-2021 12:32:06 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884008
Page 99 of 189
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
2Feb-10-2021 12:32:06 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884009
Page 100 of 189
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
3Feb-10-2021 12:32:06 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884010
Page 101 of 189
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
4Feb-10-2021 12:32:06 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884011
Page 102 of 189
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormFeb-10-2021 12:32:26 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884012
Page 103 of 189
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
1Feb-10-2021 12:32:26 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884013
Page 104 of 189
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
2Feb-10-2021 12:32:26 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884014
Page 105 of 189
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
3Feb-10-2021 12:32:26 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884015
Page 106 of 189
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
4Feb-10-2021 12:32:26 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884016
Page 107 of 189
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-24-2021 16:59:21 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-21-2021 18:32:27 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-16-2021 12:52:50 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Martina
Davalli N/A Feb-10-2021 12:31:26 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0884017
Page 108 of 189
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
N/A
Approved Nov-03-2020 17:22:12 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-03-2020 10:04:03 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-30-2020 15:53:57 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-30-2020 12:38:05 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-30-2020 12:20:06 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0884018
Page 109 of 189
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 Oct-29-2020 11:53:02 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-26-2020 19:15:09 (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.
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884019
Page 110 of 189
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-27-2020 15:21:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-27-2020 15:21:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884020
Page 111 of 189
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-27-2020 15:21:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Aug/27/2020Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884021
Page 112 of 189
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-27-2020 12:00:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12314465Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-27-2020 11:59:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1954Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020 15:22:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-27-2020 15:22:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-27-2020 15:22:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884022
Page 113 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020 15:22:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884023
Page 114 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-27-2020 15:23:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-27-2020 15:23:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020 15:23:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884024
Page 115 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Sep-01-2020 08:59:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Erectile dysf
unction
Start Date: Aug/1/2019
Ongoing: YESTranscription Error
Aug-27-2020 15:23:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Erectile dysfunctio
n (post-prostate su
rgery)
Start Date
:Aug/1/2019
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-27-2020 15:23:31
(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-01-2020
11:46:15
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1:
ClosedDiscrepancy has
been closed.
Sep-01-2020 ACV0PFEINFP6000 auto query Query 1: Transcription
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884025
Page 116 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
08:59:57
(UTC-03:00)
City of
Buenos Aires(autoquery) Answer
edError
Sep-01-2020
08:59:57
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data En
try:
Erectile
dysfunct
ionTranscription
Error
Aug-28-2020
02:06:25
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1:
OpenedMultiple concepts
in the term
ERECTILE
DYSFUNCTION
(POST-
PROSTATE
SURGERY). Split
the term into
ERECTILE
DYSFUNCTION
and
POST-PROSTATE
SURGERY and
report as 2
separate entries.
Thank you.
Aug-27-2020
15:23:31
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data En
try:
Erectile
dysfunct
ion (post
-prostate
surgery)Initial Entry
1.a Start Date:
Date Location User Value Reason
Aug-27-2020 15:23:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/1/2019Initial Entry
1.a Ongoing:
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884026
Page 117 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Aug-27-2020 15:23:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-27-2020 15:23:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Type 2 diab
etes
Start Date: Apr/1/2014
Ongoing: YESInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884027
Page 118 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.b Line/MH Number:
Date Location User Value Reason
Aug-27-2020 15:23:51
(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
Aug-27-2020 15:23:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type 2 diabetesInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-27-2020 15:23:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Apr/1/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-27-2020 15:23:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-01-2020 08:58:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:3
Medical History
Term:Prostate can
cer
Start Date: Oct/1/2018Transcription Error
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884028
Page 119 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Ongoing: NO
End Date:
Jun/1/20
19
Aug-27-2020 15:24:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:Prostate can
cer
Start Date: Dec/1/2018
Ongoing: NO
End Date:
Jun/1/20
19Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884029
Page 120 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.c Line/MH Number:
Date Location User Value Reason
Aug-27-2020 15:24:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 15:24:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Prostate cancerInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-01-2020 08:58:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/1/2018Transcription Error
Aug-27-2020 15:24:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/1/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-27-2020 15:24:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
Jun/1/2019Initial Entry
1.d
Date Location User Value Reason
Sep-01-2020 08:59:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884030
Page 121 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Medical Histor
y Term:Radical Prostat
ectomy
Start Date: Dec/1/2018
Ongoing: NO
End Date:
Dec/15/2018
1.d Line/MH Number:
Date Location User Value Reason
Sep-01-2020 08:59:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 08:59:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Radical ProstatectomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-01-2020 08:59:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/1/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-01-2020 08:59:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/15/2018Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884031
Page 122 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020 15:24:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-27-2020 15:24:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
74.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-27-2020 15:24:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-27-2020 15:24:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
176.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-27-2020 15:24:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0884032
Page 123 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-27-2020 15:24:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24.0Initial Entry
7.a
Date Location User Value Reason
Aug-27-2020 15:24:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifi
er::1
Temperature: 36.7
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-27-2020 15:24:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-27-2020 15:24:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-27-2020 15:24:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884033
Page 124 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-27-2020 15:24:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884034
Page 125 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-27-2020 15:24:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-27-2020 15:24:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
242957Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884035
Page 126 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 15:24:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 15:24:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 15:04:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020 02:23:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-27-2020 15:24:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-27-2020 15:24:51
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884036
Page 127 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires Date of Collection:
Aug/27/2020
5.a
Date Location User Value Reason
Aug-28-2020 15:04:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BPTFZBInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 15:04:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BPTFZBInitial Entry
5.b
Date Location User Value Reason
Aug-28-2020 15:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BPTFZCInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020 15:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BPTFZCInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020 15:04:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BPTFZDInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884037
Page 128 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c Sample ID
Date Location User Value Reason
Aug-28-2020 15:04:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BPTFZDInitial Entry
5.d
Date Location User Value Reason
Aug-28-2020 18:15:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BLBJ9HInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-28-2020 18:15:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BLBJ9HInitial Entry
5.e
Date Location User Value Reason
Aug-28-2020 18:15:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BLBJ9JInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-28-2020 18:15:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BLBJ9JInitial Entry
5.f
Date Location User Value Reason
Aug-28-2020 18:15:36 ACV0PFEINFP6000 Alan Colombo Data Entry: Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884038
Page 129 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00) City of
Buenos AiresSample ID: BLBJ9K
5.f Sample ID
Date Location User Value Reason
Aug-28-2020 18:15:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BLBJ9KInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884039
Page 130 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 15:24:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 15:24:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 12:26:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020 02:23:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-27-2020 15:24:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-27-2020 15:24:58
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884040
Page 131 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires Date of Collection:
Aug/27/2020
5.a
Date Location User Value Reason
Aug-28-2020 12:26:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPTFHCInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 12:26:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPTFHCInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884041
Page 132 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-27-2020 15:25:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020 15:25:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020 15:25:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-27-2020 15:25:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/27/2020 12:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020 15:25:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884042
Page 133 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-27-2020 15:25:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-27-2020 15:25:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-27-2020 15:25:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-27-2020 15:25:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884043
Page 134 of 189
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-27-2020 15:25:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E
-DIARY NOT COLLECTED
FOR THIS SUBJECTInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884044
Page 135 of 189
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020 13:41:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0884045
Page 136 of 189
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 13:41:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 13:41:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 36.6
Temperature Uni
t:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 13:41:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 13:41:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020 13:41:51 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0884046
Page 137 of 189
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00) City of
Buenos AiresC
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 13:41:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0884047
Page 138 of 189
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 09:47:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 09:47:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020 12:30:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Sep-16-2020 09:48:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-16-2020 09:47:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-16-2020 09:47:15
(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
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884048
Page 139 of 189
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
as appropriate.
Sep-16-2020 09:47:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020 09:48:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BP1RD9Transcription Error
(DELETED)
Sep-16-2020 09:47:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BP1RD9Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 09:48:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BP1RD9Transcription Error
(DELETED)
Sep-16-2020 09:47:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BP1RD9Initial Entry
5.b
Date Location User Value Reason
Sep-16-2020 12:30:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP1RCBInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884049
Page 140 of 189
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.b Sample ID
Date Location User Value Reason
Sep-16-2020 12:30:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP1RCBInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884050
Page 141 of 189
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 13:42:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 13:42:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 13:42:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 13:42:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/15/2020 14:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 13:42:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0884051
Page 142 of 189
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-18-2020 13:42:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020 13:42:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020 13:42:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-18-2020 13:42:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0884052
Page 143 of 189
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020 09:13:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0884053
Page 144 of 189
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 09:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 09:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 12:01:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 09:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-19-2020 09:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0884054
Page 145 of 189
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-19-2020 12:01:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP1PGSInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020 12:01:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP1PGSInitial Entry
5.b
Date Location User Value Reason
Oct-19-2020 12:12:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLBKF6Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020 12:12:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLBKF6Initial Entry
5.c
Date Location User Value Reason
Oct-19-2020 12:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLBKFMInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020 12:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLBKFMInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884055
Page 146 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-28-2020 08:47:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Sep-28-2020 08:43:37
(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.
Sep-28-2020 08:43:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Sep-28-2020 08:43:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/27/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Sep-28-2020 08:43:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884056
Page 147 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/27/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Nov-03-2020 13:00:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-03-2020 10:04:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Nov-03-2020 10:04:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Reso
lved:
Sep/29/2020New Information
Nov-02-2020 23:56:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: Convalescent
visit occurred but
Date of Last
Symptom
Resolved is
missing. Please
confirm symptoms
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0884057
Page 148 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
are still ongoing. If
symptoms have
resolved update
response for
Symptom ongoing
as 'No' and add
date resolved.
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCRE
ASED COUGHInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0884058
Page 149 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Symptom
Present:NO
4.b Symptoms:
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUG
HInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREAS
ED SHORTNESS OF
BREATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884059
Page 150 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.c Symptoms:
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHOR
TNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0884060
Page 151 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREA
SED MUSCLE PAI
N
Symptom
Present:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSC
LE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMELL
Symptom
Present:NOInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884061
Page 152 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.f Symptoms:
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREA
SED SORE THRO
AT
Sympto
m Presen
t:YESInitial Entry
4.g Symptoms:
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE
THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0884062
Page 153 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.h
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHE
A
Symptom Presen
t:YESInitial Entry
4.h Symptoms:
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: VOMITIN
G
Symptom Presen
t:NOInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884063
Page 154 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.i Symptoms:
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Sep-28-2020 08:45:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Sep-28-2020 08:45:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms - Other: FATIGUEInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Sep-28-2020 08:45:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884064
Page 155 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Sep-28-2020 08:46:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884065
Page 156 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Sep-28-2020 08:46:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/27/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Sep-28-2020 08:46:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Sep-28-2020 08:46:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Sep-28-2020 08:46:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Sep-28-2020 08:46:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TE
STInitial Entry
6. Trade Name:
Date Location User Value Reason
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884066
Page 157 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-28-2020 08:46:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ATILA BIOSYSTEMS IAMP
COVID-19 DETECTION KITInitial Entry
7. Test Result:
Date Location User Value Reason
Sep-28-2020 08:46:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884067
Page 158 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 08:46:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 08:46:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020 08:46:27
(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
Sep-28-2020 08:46:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SAMPLE COLLECT BY TEA
M PHYSICIANInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884068
Page 159 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 08:47:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 08:47:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-28-2020 08:47:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-28-2020 08:47:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/27/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884069
Page 160 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-28-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPWSKCInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-28-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPWSKCInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0884070
Page 161 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner
:SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:EMERGEN
CY ROOM
Occurrence of Vi
sits or Contacts:NOInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884071
Page 162 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practit
ioner:PRIMARY C
ARE PHYSIC
IAN
Occurrence of
Visits or Cont
acts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIA
NInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0884072
Page 163 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.d
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitione
r:URGENT
CARE
Occurrence of Visi
ts or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practi
tioner:TELEPHONE
CONSULTAT
ION
Occurrence of
Visits or Cont
acts:NOInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884073
Page 164 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIO
NInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits o
r Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0884074
Page 165 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Sep-28-2020 08:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884075
Page 166 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/27/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Sep-28-2020 08:51:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNE
SSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Sep-28-2020 08:51:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-02-2020 07:47:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-01-2020 16:29:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Oct-01-2020 16:29:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
Sep-29-2020 04:28:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: The response
for "Toxicity
Grade" is missing.
Kindly review and
update.
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0884076
Page 167 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/29/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-29-2020 11:53:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/29/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-29-2020 11:53:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884077
Page 168 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-29-2020 11:53:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020 11:53:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020 12:08:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-29-2020 16:00:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-29-2020 11:53:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-29-2020 11:53:10
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884078
Page 169 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires Date of Collection:
Oct/29/2020
5.a
Date Location User Value Reason
Oct-30-2020 12:08:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ4DC2Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-30-2020 12:08:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ4DC2Initial Entry
5.b
Date Location User Value Reason
Oct-30-2020 12:09:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ4DCHInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-30-2020 12:09:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ4DCHInitial Entry
5.c
Date Location User Value Reason
Oct-30-2020 12:38:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPW5Z5Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884079
Page 170 of 189
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c Sample ID
Date Location User Value Reason
Oct-30-2020 12:38:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPW5Z5Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884080
Page 171 of 189
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-23-2020 09:01:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-23-2020 09:01:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-23-2020 09:01:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884081
Page 172 of 189
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-12-2021 01:14:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-11-2021 14:07:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Adolfo Gonzalez Query 1: Answered changed per query
Feb-11-2021 08:33:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Erroneous Visit is
marked, but date
of visit is entered.
Please either
untick the
erroneous visit
button if visit
occurred, or mark
any forms
containing data
within this visit as
Not Done/Not
Applicable at the
form level.
Feb-10-2021 12:31:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Erroneous Visit is
marked, but date
of visit is entered.
Please either
untick the
erroneous visit
button if visit
occurred, or mark
any forms
containing data
within this visit as
Not Done/Not
Applicable at the
form level.
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0884082
Page 173 of 189
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Feb-10-2021 12:31:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina Davalli Data Entry:
Feb/10/2021Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Feb-10-2021 12:31:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
ERRONEOUS VISITInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884083
Page 174 of 189
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-10-2021 12:31:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884084
Page 175 of 189
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-10-2021 12:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-10-2021 12:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021 12:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-10-2021 12:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884085
Page 176 of 189
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-10-2021 12:32:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-10-2021 12:32:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021 12:32:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-10-2021 12:32:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884086
Page 177 of 189
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-10-2021 12:32:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Feb/10/2021Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884087
Page 178 of 189
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-10-2021 12:33:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-10-2021 12:33:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-10-2021 12:33:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible and NOT confirme
d to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884088
Page 179 of 189
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Mar-21-2021 18:32:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884089
Page 180 of 189
***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, Answered Queries, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Mar-21-2021 18:32:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-21-2021 18:32:27
(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
Mar-21-2021 18:32:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Penile infectionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-21-2021 18:32:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/22/2021 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-21-2021 18:32:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884090
Page 181 of 189
***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, Answered Queries, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Mar-21-2021 18:32:27
(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
Mar-24-2021 02:38:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed SDB updated
Mar-22-2021 15:44:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Reissued:Candidate pending SDB
update
Mar-22-2021 10:16:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered SAE inicial form
was sent on
20MAR.
Mar-22-2021 06:30:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened SAE RECON:
Penile
infection(Onset
date: 22JAN2021)
is not reported to
Safety database but
marked serious on
AE CRF. Confirm
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the
event on AE CRF
Mar-22-2021 06:30:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Deleted not yet in SDB
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0884091
Page 182 of 189
***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, Answered Queries, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Mar-21-2021 18:32:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Penile
infection: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Mar-21-2021 18:32:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result in
death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabi
lity/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious event
YESInitial Entry
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.
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884092
Page 183 of 189
***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, Answered Queries, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Mar-21-2021 18:32:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-29-2021
14:32:38
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query 1
: Answ
eredThe subject
underwent
surgery for
erectile
dysfunction in
January 2021,
which was
scheduled since
March 2020.
For this reason,
it is not loaded
in Medical
history or as an
adverse event.
Mar-29-2021
10:31:28
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1
: Opene
dPlease review
"If not related
to study
treatment
other" field, the
following text
was indicated
in the comment
field [Erectile
dysfunction].
Any symptoms,
AEs or other
key data should
be collected on
the appropriate
page. Please
review and
update as
necessary.
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0884093
Page 184 of 189
***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, Answered Queries, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Mar-21-2021
18:32:27
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s), t
his ev
ent is
due to
:
OT
HER
If
Ot
her
, sp
eci
fy:
E
re
ct
il
e
d
y
sf
u
n
ct
io
n
s
u
rInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0884094
Page 185 of 189
***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, Answered Queries, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
g
er
y
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-21-2021 18:32:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-21-2021 18:32:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-21-2021 18:32:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-21-2021 18:32:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-21-2021 18:32:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0884095
Page 186 of 189
***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, Answered Queries, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Mar-23-2021 06:08:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2021313544Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884096
Page 187 of 189
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-10-2021 12:33:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Feb/10/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-10-2021 12:33:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATIO
NInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0884097
Page 188 of 189
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-23-2020 09:01:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-27-2020 15:24:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-27-2020 15:23:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-23-2020 09:01:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/19/2020Initial Entry
Aug-27-2020 15:24:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
Aug-27-2020 15:23:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0884098
Page 189 of 189
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314465 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-26-2020 19:14:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2ef2\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0884099