Document text
Page 1 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005889
Page 2 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/25/2020
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005890
Page 3 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Demography
1.Subject ID [44441979]
2.Birth Date: /1990
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005891
Page 4 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005892
Page 5 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005893
Page 6 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005894
Page 7 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005895
Page 8 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005896
Page 9 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
2.Weight: [77.9]
3.Unit: kg
4.Height: [167.0]
5.Unit: cm
6.Body Mass Index: [27.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005897
Page 10 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/25/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005898
Page 11 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/25/2020
2.Randomization Number: [100195]
3.Randomization Group: [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005899
Page 12 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BRVRZS]
5.bSample ID [BRVRZZ]
5.cSample ID [BHXGJ0]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005900
Page 13 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BPWC0M]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005901
Page 14 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/25/2020 16:20
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
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005902
Page 15 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005903
Page 16 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005904
Page 17 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Temperature: Not Done
[ ]Comments
Unit: Not Done Comments
Temperature Location: Not Done Comments
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005905
Page 18 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005906
Page 19 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005907
Page 20 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005908
Page 21 of 176
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005909
Page 22 of 176
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005910
Page 23 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005911
Page 24 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005912
Page 25 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005913
Page 26 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005914
Page 27 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005915
Page 28 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005916
Page 29 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005917
Page 30 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005918
Page 31 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005919
Page 32 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005920
Page 33 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005921
Page 34 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005922
Page 35 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005923
Page 36 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005924
Page 37 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005925
Page 38 of 176
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005926
Page 39 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005927
Page 40 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Unplanned Assessments
1.Assessments
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005928
Page 41 of 176
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instance
1.ADVERSE EV
ENT 1 EXPOSURE DURING PREG
NANCY Sep/25/2020 1
6:20 YES Repeating
Pages
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005929
Page 42 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[EXPOSURE DURING PREGNANCY]
4.Start Date Time: Sep/25/2020 16:20
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[not applicable]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005930
Page 43 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
13.What was the outcome of this adverse
event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005931
Page 44 of 176
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005932
Page 45 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of Medication
Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005933
Page 46 of 176
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
1. Repeating
Pages
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005934
Page 47 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005935
Page 48 of 176
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005936
Page 49 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005937
Page 50 of 176
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005938
Page 51 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005939
Page 52 of 176
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005940
Page 53 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005941
Page 54 of 176
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/15/2020
2.Phase of Disposition: VACCINATION
3.Status: PREGNANCY
4.Specify Status: [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005942
Page 55 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005943
Page 56 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005944
Page 57 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005945
Page 58 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005946
Page 59 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005947
Page 60 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005948
Page 61 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005949
Page 62 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005950
Page 63 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005951
Page 64 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005952
Page 65 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Nov/11/2020 Comments
2.Phase of Disposition: FOLLOW-UP Comments
3.Status: WITHDRAWAL BY SUBJECT Comments
4.Specify Status: [the decision to stop participating is due to particular reasons] Comments
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005953
Page 66 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005954
Page 67 of 176
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005955
Page 68 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005956
Page 69 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Nov/11/2020
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005957
Page 70 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005958
Page 71 of 176
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/11/2020
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005959
Page 72 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005960
Page 73 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Gonzalo Perez
Marc Approved Jan-22-2021 17:20:30 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, GonzaloPerez, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005961
Page 74 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-25-2020 19:58:05 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005962
Page 75 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-25-2020 19:58:40 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005963
Page 76 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormNov-11-2020 10:53:53 (UTC-03:00) City of
Buenos AiresNOT DONE
FormNov-11-2020 10:53:31 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005964
Page 77 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
1Nov-11-2020 10:53:31 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005965
Page 78 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
2Nov-11-2020 10:53:31 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1005966
Page 79 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormNov-11-2020 12:03:48 (UTC-03:00) City of
Buenos AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005967
Page 80 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
1Nov-11-2020 12:03:48 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005968
Page 81 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
2.aNov-11-2020 12:03:48 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005969
Page 82 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
2.aNov-11-2020 12:03:48 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005970
Page 83 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
2.aNov-11-2020 12:03:48 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005971
Page 84 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormNov-11-2020 12:04:07 (UTC-03:00) City of
Buenos AiresThe volunteer withdraws consent to participate in
the study
Not Done
FormNov-10-2020 10:23:17 (UTC-03:00) City of
Buenos Aires
FormNov-10-2020 10:23:00 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005972
Page 85 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
1Nov-11-2020 12:04:07 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
1Nov-10-2020 10:23:17 (UTC-03:00) City of Buenos
Aires
1Nov-10-2020 10:23:00 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005973
Page 86 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
2Nov-11-2020 12:04:07 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
2Nov-10-2020 10:23:17 (UTC-03:00) City of Buenos
Aires
2Nov-10-2020 10:23:00 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005974
Page 87 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
3Nov-11-2020 12:04:07 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
3Nov-10-2020 10:23:17 (UTC-03:00) City of Buenos
Aires
3Nov-10-2020 10:23:00 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005975
Page 88 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
4Nov-11-2020 12:04:07 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
4Nov-10-2020 10:23:17 (UTC-03:00) City of Buenos
Aires
4Nov-10-2020 10:23:00 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005976
Page 89 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
5Nov-11-2020 12:04:07 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
5Nov-10-2020 10:23:17 (UTC-03:00) City of Buenos
Aires
5Nov-10-2020 10:23:00 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005977
Page 90 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
6.aNov-11-2020 12:04:07 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
6.aNov-10-2020 10:23:17 (UTC-03:00) City of Buenos
Aires
6.aNov-10-2020 10:23:00 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005978
Page 91 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
6.aNov-11-2020 12:04:07 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
6.aNov-10-2020 10:23:17 (UTC-03:00) City of Buenos
Aires
6.aNov-10-2020 10:23:00 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005979
Page 92 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
6.aNov-11-2020 12:04:07 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
6.aNov-10-2020 10:23:17 (UTC-03:00) City of Buenos
Aires
6.aNov-10-2020 10:23:00 (UTC-03:00) City of Buenos
AiresNot Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005980
Page 93 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormNov-11-2020 12:04:33 (UTC-03:00) City of
Buenos AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005981
Page 94 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
1Nov-11-2020 12:04:33 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005982
Page 95 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
2Nov-11-2020 12:04:33 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005983
Page 96 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
3Nov-11-2020 12:04:33 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005984
Page 97 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
4Nov-11-2020 12:04:33 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005985
Page 98 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormNov-11-2020 12:04:46 (UTC-03:00) City of
Buenos AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005986
Page 99 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
1Nov-11-2020 12:04:46 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005987
Page 100 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
2Nov-11-2020 12:04:46 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005988
Page 101 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
3Nov-11-2020 12:04:46 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005989
Page 102 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
4Nov-11-2020 12:04:46 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005990
Page 103 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
5Nov-11-2020 12:04:46 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005991
Page 104 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
6Nov-11-2020 12:04:46 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005992
Page 105 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
7Nov-11-2020 12:04:46 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005993
Page 106 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
8Nov-11-2020 12:04:46 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005994
Page 107 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
9Nov-11-2020 12:04:46 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005995
Page 108 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
10Nov-11-2020 12:04:46 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005996
Page 109 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
11Nov-11-2020 12:04:46 (UTC-03:00) City of Buenos
AiresThe volunteer withdraws consent to participate in
the study
Not Done
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005997
Page 110 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
6Nov-12-2020 09:53:36 (UTC-03:00) City of Buenos
AiresMaria Beretta Not Applicable
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005998
Page 111 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormNov-11-2020 12:01:23 (UTC-03:00) City of
Buenos Aires
FormNov-10-2020 10:21:33 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005999
Page 112 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
1Nov-11-2020 12:01:23 (UTC-03:00) City of Buenos
Aires
1Nov-10-2020 10:21:33 (UTC-03:00) City of Buenos
AiresNot Applicable
1Nov-07-2020 11:33:51 (UTC-03:00) City of Buenos
AiresThe subject will continue the follow up visits as per
protocol
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006000
Page 113 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
2Nov-11-2020 12:01:23 (UTC-03:00) City of Buenos
Aires
2Nov-10-2020 10:21:33 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006001
Page 114 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
3Nov-11-2020 12:01:23 (UTC-03:00) City of Buenos
Aires
3Nov-10-2020 10:21:33 (UTC-03:00) City of Buenos
AiresNot Applicable
3Nov-07-2020 11:33:01 (UTC-03:00) City of Buenos
AiresThe subject will continue the follow up visits as per
protocol
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006002
Page 115 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
4Nov-11-2020 12:01:23 (UTC-03:00) City of Buenos
Aires
4Nov-10-2020 10:21:33 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006003
Page 116 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Gonzalo Perez
Marc Approved Jan-22-2021 17:20:30 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, GonzaloPerez, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-16-2020 10:28:52 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-15-2020 17:47:33 (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-11-2020 10:53:31 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Maria Beretta Approved Nov-10-2020 10:58:27 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006004
Page 117 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, MariaBeretta, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006005
Page 118 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-25-2020 19:57:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-25-2020 19:57:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006006
Page 119 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-25-2020 19:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/25/2020Initial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006007
Page 120 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-25-2020 15:44:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
44441979Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-25-2020 15:44:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1990Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-25-2020 19:57:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-25-2020 19:57:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-25-2020 19:57:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006008
Page 121 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-25-2020 19:57:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006009
Page 122 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-25-2020 19:58:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-25-2020 19:58:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-25-2020 19:58:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006010
Page 123 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-25-2020 19:58:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
The subject is NOT known to be HIV
POSITIVEInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006011
Page 124 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020 19:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-25-2020 19:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
77.9Initial Entry
3. Unit:
Date Location User Value Reason
Sep-25-2020 19:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-25-2020 19:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
167.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-25-2020 19:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-1006012
Page 125 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-25-2020 19:59:25
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.9Initial Entry
7.a
Date Location User Value Reason
Sep-25-2020 19:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 37.0
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-25-2020 19:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-25-2020 19:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-25-2020 19:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-25-2020 19:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-1006013
Page 126 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-25-2020 19:59:42
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-25-2020 19:59:42
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-25-2020 19:59:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-25-2020 19:59:42
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-25-2020 19:59:42
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-25-2020 19:59:42
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006014
Page 127 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-25-2020 19:59:42
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-25-2020 19:59:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-25-2020 19:59:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006015
Page 128 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-25-2020 20:00:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-25-2020 20:00:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
100195Initial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006016
Page 129 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 20:01:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 20:01:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-27-2020 08:40:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-26-2020 06:29:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-25-2020 20:01:04
(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-25-2020 20:01:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-27-2020 08:40:21
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Sample ID: BRVRZSInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1006017
Page 130 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires
5.a Sample ID
Date Location User Value Reason
Sep-27-2020 08:40:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRVRZSInitial Entry
5.b
Date Location User Value Reason
Sep-27-2020 09:26:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRVRZZInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-27-2020 09:26:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRVRZZInitial Entry
5.c
Date Location User Value Reason
Sep-27-2020 10:15:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHXGJ0Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-27-2020 10:15:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHXGJ0Initial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006018
Page 131 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 20:01:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 20:01:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-27-2020 08:49:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-26-2020 06:29:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-25-2020 20:01:13
(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.
Sep-25-2020 20:01:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-27-2020 08:49:44
(UTC-03:00) City ofACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BPWC0MInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006019
Page 132 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires
5.a Sample ID
Date Location User Value Reason
Sep-27-2020 08:49:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BPWC0MInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006020
Page 133 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-25-2020 20:01:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020 20:01:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020 20:01:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-07-2020
23:22:41
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1
: ClosedAuto closed by Validation
Check:
VC_EC001_2_12_AN
Nov-07-2020
19:05:26
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query 1
: Answe
redThe original value is
correct. The subject
received the treatment on 25
sept 2020. The
discontinuation was 15 oct
2020. Thank you
Nov-07-2020
17:39:28
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1
: Opene
dDMW5309918;Date is after
‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Treatment eCRF. Please
clarify or correct.
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b)
(4),
(b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006021
Page 134 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-25-2020
20:01:38
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data E
ntry:
Sep/25/
2020 16
:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020 20:01:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-25-2020 20:01:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-25-2020 20:01:38
(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-25-2020 20:01:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-25-2020 20:01:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006022
Page 135 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-25-2020 20:01:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006023
Page 136 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-11-2020 10:53:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Nov-11-2020 10:53:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006024
Page 137 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Nov-11-2020 12:03:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.a
Date Location User Value Reason
Nov-11-2020 12:03:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: Not Done
Temperature: Not Done
Temperature Unit: Not Done
Temperature Location:: Not DoneInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-11-2020 12:03:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.a Temperature:
Date Location User Value Reason
Nov-11-2020 12:03:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.a Unit:
Date Location User Value Reason
Nov-11-2020 12:03:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-11-2020 12:03:48
(UTC-03:00) City of BuenosACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006025
Page 138 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Aires
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1006026
Page 139 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-11-2020 12:04:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Nov-10-2020 10:23:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 10:23:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-11-2020 12:04:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Nov-10-2020 10:23:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 10:23:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-11-2020 17:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-11-2020 12:04:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Nov-11-2020 10:56:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered COMMENT
UPDATED PER
QERY
Nov-11-2020 02:59:23
(UTC-03:00) City ofACV0PFEINFP6000 Query 2: Opened DM: Subject is
discontinued hence
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1006027
Page 140 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires kindly consider
marking this form as
DOV form as Not
done by selection
form level comment
or else clarify. Thank
you.
Nov-10-2020 10:23:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 10:23:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Oct-13-2020 19:34:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-13-2020 13:34:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered this visit was never
opened, nor were
entries at all. there is
no data to load.
Oct-13-2020 10:08:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLINICAL - please
add collection date
for urine HCG test;
also result should be
entered below
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-11-2020 12:04:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Nov-10-2020 10:23:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 10:23:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-11-2020 12:04:07 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1006028
Page 141 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos AiresNot Done
Nov-10-2020 10:23:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 10:23:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Nov-11-2020 12:04:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sponsor-Defined Identifie
r:Not Don
e
Test:: Not Don
e
Result:: Not Don
e
Not Done:: Not Don
eInitial Entry
Nov-10-2020 10:23:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sponsor-Defined Identifie
r:
Test:: Not Don
e
Result::
Not Done::Initial Entry
Nov-10-2020 10:23:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sponsor-Defined Identifie
r:Not Don
e
Test:: Not Don
e
Result:: Not Don
e
Not Done:: Not Don
eInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-11-2020 12:04:07
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1006029
Page 142 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires
Nov-10-2020 10:23:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 10:23:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Nov-10-2020 10:23:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Nov-11-2020 12:04:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Nov-10-2020 10:23:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 10:23:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
Nov-11-2020 12:04:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Nov-10-2020 10:23:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 10:23:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006030
Page 143 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020 12:04:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020 12:04:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-15-2020 13:23:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-15-2020 12:53:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The requested form
has already been
loaded.
Nov-15-2020 08:08:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: Please consider
updating Withdrawal
of consent form,
Thank you.
Nov-11-2020 12:04:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-11-2020 12:04:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006031
Page 144 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-11-2020 12:04:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-11-2020 12:04:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-11-2020 12:04:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Nov-12-2020
18:14:57
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Nov-12-2020
10:02:45
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
1: Ans
weredsubject is pregnant. Thus
didn´t recieve second dose of
investigation product
Nov-11-2020
20:43:06
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5359694;Randomization
number is recorded and the
final disposition date is
present on the Disposition -
Follow-up eCRF, but there is
no dosing date present on the
Treatment eCRF. Please
review and update as
appropriate.
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006032
Page 145 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nov-11-2020
12:04:46
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data
Entry
:
Not D
oneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-11-2020 12:04:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-11-2020 12:04:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Nov-11-2020 12:04:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Nov-11-2020 12:04:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Nov-11-2020 12:04:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-11-2020 12:04:46 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006033
Page 146 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of Buenos
AiresNot Done
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Nov-11-2020 12:04:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006034
Page 147 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Oct-13-2020 09:09:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006035
Page 148 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020 09:09:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020 09:09:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-13-2020 09:09:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EXPOSURE DURING PREGNANCYInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-16-2020 15:56:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 11: Closed Response satisfies
query
Dec-16-2020 10:28:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 11: Answered New Information
Dec-16-2020 10:28:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020 16:20New Information
Dec-15-2020 01:29:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 11: Opened Clinical - Event end
date is 05Sep20;
however, SAE report
end date is 25Sep20. As
Injection #1 occurred
on 25Sep20, exposure
during pregnancy
begins on this date;
please review and
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006036
Page 149 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
update
Nov-12-2020 18:56:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 9: Closed Response satisfies
query
Nov-12-2020 18:56:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 10: Closed Response satisfies
query
Nov-12-2020 13:11:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 8: Closed Response satisfies
query
Nov-12-2020 09:52:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria Beretta Query 10: Answered Subject has a negative
pregnancy test during
visit1, but then the
diagnosis was made. As
last menstruation date
was 5 SEP, that is the
date considered as
conception.
Nov-12-2020 09:47:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria Beretta Query 9: Answered The pregnancy start
date is considered as the
last menstruation date
that was on 5 SEP
2020. Despite that,
subject had a negative
pregnancy test on first
visit and therefore,
received the first dose.
Nov-12-2020 09:45:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 10: Opened For EXPOSURE
DURING
PREGNANCY: Start
date 05/Sep/2020 is
before V1D1VX1L
visit date 25/Sep/2020.
Please review and
update as appropriate.
Nov-12-2020 09:45:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 9: Opened Start date is before
Consent Date 25/Sep
/2020.
Nov-12-2020 09:45:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria Beretta Data Entry:
Sep/5/2020 UNK:UNKTranscription Error
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006037
Page 150 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nov-12-2020 09:43:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 8: Answered Transcription Error
Nov-12-2020 09:43:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria Beretta Data Entry:
UNK/UNK/2020 UNK:UNKTranscription Error
Nov-12-2020 06:54:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Balaji Prabu R Query 8: Opened As per completion
guidelines version 10.0,
If conception occurred
prior to vaccination 1,
time to be recorded as
UNK:UNK. Please
review and update as
appropriate. Else
clarify.
Nov-07-2020 13:43:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Nov-05-2020 07:38:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Reissued:Candidate SAE RECON: Pending
SDB update
Nov-04-2020 19:36:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina Davalli Query 3: Answered The onset date is
correct, and the form
has been sent. Thank
you.
Nov-04-2020 08:12:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Reissued:Opened SAE RECON 4: Thank
you for the update.
Please confirm if a
follow up AEM form
was submitted to update
onset date in Safety
database.
Nov-03-2020 15:00:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Changed Information
Nov-03-2020 15:00:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Sep/25/2020 16:20Changed Information
Nov-03-2020 10:07:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Reissued:Opened SAE RECON 3: Per
latest EDP guideline,if
conception occurred
prior to vaccination 1,
Date of AE Onset =
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006038
Page 151 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of vaccination.The
date of vaccination 1
for this subject is
25Sep2020. Please
confirm and update
accordingly.
Nov-02-2020 19:55:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Query 3: Answered Last menstrual period
date: 5SEP2020-
Pregnancy test positive
:9OCT2020. Please
advise
Oct-29-2020 06:48:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Reissued:Opened SAE RECON 2: As
exposure to pregnancy
can only occur at the
time of vaccination,
onset date should reflect
the date of vaccination.
The date of vaccination
is 25Sep2020. Please
confirm and update
accordingly.
Oct-21-2020 03:23:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 7: Closed Response satisfies
query
Oct-21-2020 03:22:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 6: Closed Response satisfies
query
Oct-21-2020 02:19:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Reissued:Candidate SAE RECON: For
Clinical review
Oct-20-2020 13:16:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 7: Answered On 09OCT2020 a urine
pregnancy test was
performed with a
positive result.
05SEP2020 is the date
of the last menstruation.
Oct-20-2020 13:16:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 6: Answered On 09OCT2020 a urine
pregnancy test was
performed with a
positive result.
05SEP2020 is the date
of the last menstruation.
Oct-20-2020 13:14:50
(UTC-03:00) City ofACV0PFEINFP6000 auto query
(autoquery)Query 7: Opened For EXPOSURE
DURING
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006039
Page 152 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires PREGNANCY: Start
date 05/Sep/2020 is
before V1D1VX1L
visit date 25/Sep/2020.
Please review and
update as appropriate.
Oct-20-2020 13:14:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 6: Opened Start date is before
Consent Date 25/Sep
/2020.
Oct-20-2020 13:14:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Transcription Error
Oct-20-2020 13:14:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/5/2020 22:00Transcription Error
Oct-18-2020 22:41:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 5: Closed Response satisfies
query
Oct-18-2020 22:41:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Oct-17-2020 09:56:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Reissued:Opened SAE RECON 1: Onset
date updated to
19Sep2020 in AE CRF.
Please confirm if a
follow up AEM form
was submitted to also
update onset date in
Safety database.
Oct-16-2020 12:59:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 5: Answered On 09OCT2020 a urine
pregnancy test was
performed with a
positive result. 19SEP
is the estimated date of
conception. The
gestation time at the
initial exposure is 2
weeks and 6 days.
Oct-16-2020 12:58:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Answered On 09OCT2020 a urine
pregnancy test was
performed with a
positive result. 19SEP
is the estimated date of
conception.
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-1006040
Page 153 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-16-2020 12:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 5: Opened For EXPOSURE
DURING
PREGNANCY: Start
date 19/Sep/2020 is
before V1D1VX1L
visit date 25/Sep/2020.
Please review and
update as appropriate.
Oct-16-2020 12:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 4: Opened Start date is before
Consent Date 25/Sep
/2020.
Oct-16-2020 12:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered New Information
Oct-16-2020 12:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020 22:00New Information
Oct-16-2020 07:19:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Opened SAE RECON:
AER#2020394406, ,per
Clinical review 'The
subject's first day of last
menstrual period was
on 05Sep2020 but the
estimated date of
conception is reported
to be 19Sep2020.
Please confirm correct
onset date and update
accordingly.
Oct-14-2020 02:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Oct-14-2020 02:06:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-13-2020 09:15:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered On 09OCT2020 a urine
pregnancy test was
performed with a
positive result. On
5SEP2020 was the last
menstruation of the
participant.
Oct-13-2020 09:14:02
(UTC-03:00) City ofACV0PFEINFP6000 Query 1: Answered On 09OCT2020 a urine
pregnancy test was
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-1006041
Page 154 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires performed with a
positive result. On
5SEP2020 was the last
menstruation of the
participant.
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006042
Page 155 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
4. Start Date Time:
Date Location User Value Reason
Oct-13-2020 09:09:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For EXPOSURE
DURING
PREGNANCY: Start
date 05/Sep/2020 is
before V1D1VX1L
visit date 25/Sep/2020.
Please review and
update as appropriate.
Oct-13-2020 09:09:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start date is before
Consent Date 25/Sep
/2020.
Oct-13-2020 09:09:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/5/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-12-2020 18:29:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Nov-12-2020 09:50:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria Beretta Query 3: Answered After the diagnosis of
pregnancy the subject
decided to withdraw
consent from the
study.
Nov-11-2020 12:02:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
ongoing. Please
review and update as
appropriate.
Nov-08-2020 08:57:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-07-2020 10:23:12
(UTC-03:00) City ofACV0PFEINFP6000 Query 2: Answered Yes, ongoing. The
subjet is still pregnan.
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006043
Page 156 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires
Nov-07-2020 09:52:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Sandip
Namdeorao
SuryawanshiQuery 2: Reissued:Opened Kindly verify and
confirm if AE is still
ongoing. Thank you.
Nov-06-2020 18:49:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered Original value is
correct
Nov-06-2020 18:14:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
ongoing. Please
review and update as
appropriate.
Oct-14-2020 09:03:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-14-2020 09:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
ongoing. Please
review and update as
appropriate.
Oct-13-2020 09:09:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-12-2020 13:13:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-12-2020 09:53:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria Beretta Data Entry:
Not ApplicableInitial Entry
Nov-12-2020 09:53:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006044
Page 157 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nov-12-2020 09:53:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria Beretta Data Entry: Transcription Error
Nov-12-2020 06:57:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Balaji Prabu R Query 1: Opened Toxicity grade is not
expected for
pregnancy related
adverse events, hence
please remove the
toxicity and add item
level comment as
NOT APPLICABLE.
Oct-13-2020 09:09:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-18-2020 22:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Oct-17-2020 09:57:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Oct-16-2020 09:41:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered New Information
Oct-16-2020 09:41:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New Information
Oct-16-2020 09:41:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NONew Information
Oct-16-2020 07:14:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Opened SAE RECON:The
pregnancy was
appropriately reported
to safety; however,
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (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) (4)
FDA-CBER-2021-5683-1006045
Page 158 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
seriousness criteria is
met only if there is an
abnormal pregnancy
outcome/protocol
section 8.3.5.1. Please
update seriousness
criteria accordingly.
Oct-16-2020 07:13:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed recorded as non serious
in SBD
Oct-14-2020 08:05:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE
RECON:EXPOSURE
DURING
PREGNANCY(Onset
date:14Oct2020) 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
Oct-13-2020 10:59:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened CLINICAL The
pregnancy was
appropriately reported
to safety; however,
seriousness criteria is
met only if there is an
abnormal pregnancy
outcome (see protocol
section 8.3.5.1). Please
update seriousness
criteria accordingly.
Oct-13-2020 09:09:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE EXPOSURE
DURING
PREGNANCY:
Response to "Is the
adverse event serious?"
is 'Yes' but "Serious
Adverse Event
Number" is blank.
Oct-13-2020 09:09:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated wiInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006046
Page 159 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
th congenital anomaly or birth de
fect?
NO
Did this serious event result in de
ath?
NO
Did this serious event require or
prolong hospitalization?
NO
Did this serious event result in pe
rsistent or significant disability/in
capacity?
NO
Is this serious event life threateni
ng?
NO
Other medically important seriou
s 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.
Date Location User Value Reason
Oct-13-2020 09:09:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-13-2020 09:09:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHERInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006047
Page 160 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
If Other, specify:
not applicable
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-06-2020
05:16:28
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 2: Clos
edResponse
satisfies query
Nov-04-2020
20:04:01
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 2: Ans
weredIt is clarified that
as a result of the
event it was
necessary for the
subject to be
discontinued
from the study
due to exposure
during
pregnancy. An
event follow-up
form is sent with
this clarification.
Thank you.
Nov-04-2020
07:13:35
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 2: Ope
nedThe Adverse
Event Action
Taken is DRUG
WITHDRAWN
but reason for
treatment
discontinuation
is not reported as
ADVERSE
EVENT or
DEATH. Please
review and
clarify.
Oct-14-2020
09:25:27
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Clos
edResponse
satisfies query
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b)
(4)
(b) (4)
FDA-CBER-2021-5683-1006048
Page 161 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-14-2020
09:02:30
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Ans
weredThe EOT has
already been
loaded
Oct-14-2020
08:47:06
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Ope
nedGPD Clinical:
please complete
the End of
Treatment CRF
page, thank you.
Oct-13-2020
09:09:01
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
DRUG WITH
DRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-13-2020 09:09:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-13-2020 09:09:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-04-2020 08:10:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-04-2020 07:43:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Data ok as is.
Nov-03-2020 15:05:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiQuery 2: Answered I've changed the
outcome to
"Unknown" as you
requested, but if I do
that and autoquery is
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (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)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006049
Page 162 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
opened because the AE
is still ongoing. Please
provide further
information on what to
do.
Nov-03-2020 14:58:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE EXPOSURE
DURING
PREGNANCY:
Response to "What
was the outcome of
this adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse event
still ongoing?" is
marked "Yes".
Nov-03-2020 14:58:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Nov-03-2020 14:58:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
UNKNOWNChanged Information
Nov-03-2020 12:09:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020394406, the
outcome in AE CRF
was reported as NOT
RECOVERED/NOT
RESOLVED.Based on
the latest EDP
guidance, outcome
should be recorded as
UNKNOWN. Please
confirm and update
accordingly.
Oct-13-2020 09:09:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006050
Page 163 of 176
***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
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-07-2020 18:02:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Nov-07-2020 16:35:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Subject will continue
in safety followup
Nov-07-2020 16:35:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOSubject will continue
in safety followup
Nov-07-2020 16:11:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Hayley Wyper Query 1: Reissued:Opened CLINQUERY: Please
review this entry in
line with FUP tab i.e.
if subject will
continue in safety
followup then please
update this field to
'no'. Field indicates
end of study not end
of treatment
Nov-06-2020 18:54:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Changed data per
query
Nov-06-2020 17:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY: Entry
indicates subject will
no longer attend visits
on the study due to
pregnancy. If this is
correct, then please
update the FUP tab to
report subject has
ceased participation
on the trial
Nov-04-2020 20:01:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESNew Information
Oct-13-2020 09:09:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006051
Page 164 of 176
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-07-2020
23:24:29
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2
: ClosedAuto closed by Validation
Check: VC_DS001_19
Nov-07-2020
19:03:17
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2
: Answe
redTranscription Error
Nov-07-2020
19:03:17
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data E
ntry:
Oct/15/
2020Transcription Error
Nov-07-2020
17:42:23
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1
: ClosedAuto closed by Validation
Check: VC_DS001_14_AN
Nov-07-2020
17:40:19
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2
: Opene
dDMW5310452;Date is
before ‘Date Written
consent Obtained’ on the
Consent form. Please clarify
or correct.
Nov-07-2020
12:13:30
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1
: Answe
redTranscription Error
Nov-07-2020
12:13:30
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data E
ntry:
Sep/5/2
020Transcription Error
Nov-06-2020
23:58:52
(UTC-03:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1
: Opene
dDMW5308130;‘Treatment
Date of
Completion/Discontinuation
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006052
Page 165 of 176
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
City of
Buenos Aires/Death' is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Oct-14-2020
09:00:54
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data E
ntry:
Oct/9/2
020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020 09:00:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-07-2020
12:12:03
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 5:
ClosedClose Auto Query
Nov-07-2020
12:11:16
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 5:
OpenedResponse to "Status" is
PREGNANCY but
"Specify Status" is
Provided.
Nov-07-2020
12:11:16
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Ent
ry:
PREGNA
NCYTranscription Error
Nov-07-2020
12:10:04
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 4:
ClosedClose Auto Query
Nov-07-2020
12:08:38
(UTC-03:00)ACV0PFEINFP6000 auto query
(autoquery)Query 4:
OpenedResponse to "Status" is
OTHER but "Specify
Status" is missing.
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1006053
Page 166 of 176
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
City of Buenos
Aires
Nov-07-2020
12:08:38
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Ent
ry:
OTHERTranscription Error
Oct-19-2020
01:48:41
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1:
ClosedResponse satisfies query.
Oct-16-2020
18:01:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 3:
ClosedClose Auto Query
Oct-16-2020
18:01:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Ent
ry:
PREGNA
NCYTranscription Error
Oct-16-2020
17:51:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 3:
OpenedStatus is reported as
Adverse Event, but there
is no Adverse Event with
'Did the adverse event
cause the subject to be
discontinued from the
study' reported as YES.
Please check and correct
the data.
Oct-16-2020
17:51:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1:
AnsweredTranscription Error
Oct-16-2020
17:51:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Ent
ry:
ADVERS
E EVENTTranscription Error
Oct-16-2020
10:44:03
(UTC-03:00)ACV0PFEINFP6000 Query 2:
ClosedQuery raised
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-1006054
Page 167 of 176
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
City of Buenos
Aires
Oct-15-2020
15:14:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 2:
AnsweredThe volunteer notified
the research team that
she performed a
pregnancy test on her
own, it was positive.
Oct-15-2020
06:11:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2:
OpenedDMW4975198;Response
to 'Status' is
PREGNANCY, but there
is no pregnancy tests
with a positive result
with a 'Collection Date'
on or before the
disposition date. Please
review and update as
appropriate.
Oct-14-2020
13:34:10
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1:
OpenedDM: As per CRF CR
Section 8.55.2, If there
are two or more reasons
for withdrawal and an
adverse event is one of
them, the adverse event
is considered the primary
reason. Kindly update
data accordingly, else
clarify, Thank you.
Oct-14-2020
09:00:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Ent
ry:
PREGNA
NCYInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-07-2020 12:12:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Nov-07-2020 12:10:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DISCONTINUED BY PREGNANC
YInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (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)
FDA-CBER-2021-5683-1006055
Page 168 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-15-2020 07:51:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-14-2020 10:43:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The EOT date is
correct, as she did not
receive a second dose
due to pregnancy. The
follow-up date is also
correct because the
volunteer withdrew
the consent for the
follow-up.
Nov-12-2020 12:30:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened GPD Clinical: please
consider if the date of
Completion should be
the same as the End
of Treatment Date,
thank you.
Nov-11-2020 12:02:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
Nov-11-2020 12:01:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 10:21:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-07-2020 11:29:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Nov-06-2020 18:48:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/25/2020Changed Information
Nov-06-2020 18:14:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/9/2020Initial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006056
Page 169 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct-14-2020 09:03:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Oct-14-2020 09:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-11-2020 12:02:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Nov-11-2020 12:01:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
Nov-10-2020 10:21:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Nov-07-2020 11:29:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Nov-06-2020 18:14:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-14-2020 09:03:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Oct-14-2020 09:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Nov-11-2020 12:02:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WITHDRAWAL BY SUBJECTInitial Entry
Nov-11-2020 12:01:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006057
Page 170 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nov-10-2020 10:21:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-07-2020 16:12:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Nov-07-2020 11:29:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-07-2020 11:29:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Nov-07-2020 07:16:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY: Please
note, this page is
related to end of study
(not end of treatment).
Please review its
completion and
confirm data correct
i.e. that subject will
no longer take part in
safety follow up
Nov-06-2020 18:54:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
PREGNANCYChanged Information
Nov-06-2020 18:47:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ADVERSE EVENTChanged Information
Nov-06-2020 18:14:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
PREGNANCYInitial Entry
Oct-14-2020 09:03:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Oct-14-2020 09:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
PREGNANCYInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-11-2020 12:02:40 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (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) (4)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-1006058
Page 171 of 176
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City of
Buenos Airesthe decision to stop participating is du
e to particular reasons
Nov-11-2020 12:01:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 10:21:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1006059
Page 172 of 176
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Nov-15-2020 12:52:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1006060
Page 173 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-11-2020 12:02:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Nov-07-2020 12:11:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Nov-07-2020 12:08:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Nov-07-2020 11:29:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Nov-06-2020 18:54:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged Information
Nov-06-2020 18:47:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged Information
Nov-06-2020 18:14:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-16-2020 18:01:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Oct-16-2020 17:51:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Oct-14-2020 09:03:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Oct-14-2020 09:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-14-2020 09:00:54
(UTC-03:00) City ofACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006061
Page 174 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Buenos Aires
Sep-25-2020 20:00:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-25-2020 19:58:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-11-2020 12:02:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/11/2020Initial Entry
Nov-07-2020 19:03:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/15/2020Transcription Error
Nov-07-2020 12:13:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/5/2020Transcription Error
Nov-07-2020 12:11:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Transcription Error
Nov-07-2020 12:08:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Transcription Error
Nov-07-2020 11:29:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Transcription Error
Nov-07-2020 11:29:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Transcription Error
Nov-06-2020 18:54:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/25/2020Changed Information
Nov-06-2020 18:48:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/25/2020Changed Information
Nov-06-2020 18:47:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Changed Information
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006062
Page 175 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Nov-06-2020 18:14:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Initial Entry
Oct-16-2020 18:01:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Transcription Error
Oct-16-2020 17:51:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Transcription Error
Oct-14-2020 09:03:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Transcription Error
Oct-14-2020 09:03:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Transcription Error
Oct-14-2020 09:01:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Initial Entry
Oct-14-2020 09:00:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Initial Entry
Sep-25-2020 20:00:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
Sep-25-2020 19:58:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-1006063
Page 176 of 176
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme
Argerich
Subject No: 44441979 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020 10:58:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria Beretta Data Entry:
Click Here to EnableInitial Entry
090177e196ae2e60\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1006064