Document text
Page 1 of 199
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000044
Page 2 of 199
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/16/2020
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000045
Page 3 of 199
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12412263]
2.Birth Date: 1952
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
WHITE
6.Racial Designation:
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1000046
Page 4 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000047
Page 5 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000048
Page 6 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000049
Page 7 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Uterine fibroids]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hysterectomy]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Allergic rhinitis]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000050
Page 8 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Osteoporosis]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000051
Page 9 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000052
Page 10 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/16/2020
2.Weight: [76.0]
3.Unit: kg
4.Height: [155.0]
5.Unit: cm
6.Body Mass Index: [31.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000053
Page 11 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/16/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000054
Page 12 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/16/2020
2.Randomization Number: [270185]
3.Randomization Group: [ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000055
Page 13 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTSX6]
5.bSample ID [BMM70K]
5.cSample ID [BMM70L]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000056
Page 14 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTSWZ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000057
Page 15 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/16/2020 13:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000058
Page 16 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000059
Page 17 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000060
Page 18 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Nov/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000061
Page 19 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/5/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000062
Page 20 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/5/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR5TW2]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000063
Page 21 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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: Nov/5/2020 12:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000064
Page 22 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/3/2020
2.Erroneous Visit
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000065
Page 23 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/3/2020
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 [BR7C94]
5.bSample ID [BS2KCZ]
5.cSample ID [BS2KD0]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000066
Page 24 of 199
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000067
Page 25 of 199
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000068
Page 26 of 199
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000069
Page 27 of 199
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000070
Page 28 of 199
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000071
Page 29 of 199
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000072
Page 30 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/14/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000073
Page 31 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/14/2020
2.Date of First Symptom
Started:Dec/10/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/18/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000074
Page 32 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Nasal obstruction]
5.bSymptoms - Other Text: [Runny nose]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000075
Page 33 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descri
ptionDevice TypeForm Insta
nce
1.Dec/12/
2020 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTIC
TEST Repeating
Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000076
Page 34 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/12/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASOPHARYNX
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT unknown]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000077
Page 35 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[Subject used site swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000078
Page 36 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/14/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR796R]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000079
Page 37 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000080
Page 38 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?YES
Has the subject been in intensive care due to potential
COVID-19 illness?
NO
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000081
Page 39 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Hospitalization CategoryHospitalization Te
rmAdmission Da
teOngoin
gForm Instance
1.HOSPITALIZATION STAT
US HOSPITAL Dec/12/2020 YES Repeating
Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000082
Page 40 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Dec/12/2020
4.Ongoing? YES
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000083
Page 41 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Treatment Ide
ntifierCon Non-Drug Treatments P
re-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000084
Page 42 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000085
Page 43 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Viral pneumonia]
Date of Diagnosis:
Jan/18/2021
3.Toxicity Grade: 2
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000086
Page 44 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category of Clinical
Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1. Repeating
Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000087
Page 45 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000088
Page 46 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category for
Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1. Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000089
Page 47 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000090
Page 48 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category f
or Lab TestVendor Name
(DERIVED)Collecti
on Date:Specim
en TypeLab ResultForm Instan
ce
1. Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000091
Page 49 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000092
Page 50 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000093
Page 51 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000094
Page 52 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000095
Page 53 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000096
Page 54 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date Time of Assess
mentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1. Repeating
Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000097
Page 55 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000098
Page 56 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000099
Page 57 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000100
Page 58 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of Assessm
entLocation of Assess
mentImaging Meth
odOverall Assessm
entForm Instance
1. Repeating
Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000101
Page 59 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000102
Page 60 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/18/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000103
Page 61 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/18/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/18/2021
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTKN2]
5.bSample ID [BRT73B]
5.cSample ID [BRT73C]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000104
Page 62 of 199
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000105
Page 63 of 199
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000106
Page 64 of 199
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Respiratory Tract
Viral infection Dec/10/2020
UNK:UNK NO
End Date Time:
Dec/18/2020 UN
K:UNK
Repeating
Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000107
Page 65 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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)[Respiratory Tract Viral infection]
4.Start Date Time: Dec/10/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/18/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000108
Page 66 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
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:
[Viral infection]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000109
Page 67 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021017983]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000110
Page 68 of 199
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categ
oryMedication
ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication E
rrors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000111
Page 69 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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[ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000112
Page 70 of 199
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000113
Page 71 of 199
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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: //
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000114
Page 72 of 199
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000115
Page 73 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000116
Page 74 of 199
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Catego
ryTreatment Ide
ntifierCon Non-Drug Treatments P
re-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000117
Page 75 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000118
Page 76 of 199
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000119
Page 77 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000120
Page 78 of 199
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000121
Page 79 of 199
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000122
Page 80 of 199
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000123
Page 81 of 199
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000124
Page 82 of 199
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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:
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000125
Page 83 of 199
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000126
Page 84 of 199
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000127
Page 85 of 199
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000128
Page 86 of 199
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000129
Page 87 of 199
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000130
Page 88 of 199
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000131
Page 89 of 199
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000132
Page 90 of 199
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000133
Page 91 of 199
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000134
Page 92 of 199
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response -
Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000135
Page 93 of 199
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000136
Page 94 of 199
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/27/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000137
Page 95 of 199
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent Date
://
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000138
Page 96 of 199
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000139
Page 97 of 199
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/3/2020
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000140
Page 98 of 199
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000141
Page 99 of 199
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Edson
Moreira Approved Feb-02-2021 16:25:58 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, EdsonMoreira, 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.
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000142
Page 100 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-16-2020 14:18:47 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000143
Page 101 of 199
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Edson
Moreira Approved Feb-02-2021 16:25:58 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, EdsonMoreira, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Jan-27-2021 15:06:03 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 17:52:49 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1000144
Page 102 of 199
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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.
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1000145
Page 103 of 199
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-16-2020
14:17:46
(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
Oct-16-2020
14:17:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000146
Page 104 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-16-2020
14:17:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consen
t Obtained
Oct/16/2020Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000147
Page 105 of 199
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-16-2020
14:17:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12412263Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-16-2020
14:17:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1952Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-16-2020
14:18:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-16-2020
14:18:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF S
PANISH ORIGINInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000148
Page 106 of 199
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-16-2020
14:18:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BLACK OR AFRICA
N AMERICAN
WHITEInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000149
Page 107 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020
14:18:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/16/2020Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000150
Page 108 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-16-2020
14:19:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020
14:19:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020
14:19:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000151
Page 109 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Oct-16-2020
14:20:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:Uterine fib
roids
Start Date: UNK/UNK
/1998
Ongoing: NO
End Date
:
UNK/U
NK/199
8Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-16-2020
14:20:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000152
Page 110 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-16-2020
14:20:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Uterine fibroidsInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-16-2020
14:20:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-16-2020
14:20:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
1.b
Date Location User Value Reason
Oct-16-2020
14:20:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical Hi
story Term
:Hysterecto
myInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000153
Page 111 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Start Date: UNK/UNK
/1998
Ongoing: NO
End Date
:
UNK/U
NK/199
8
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000154
Page 112 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Line/MH Number:
Date Location User Value Reason
Oct-16-2020
14:20:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020
14:20:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
HysterectomyInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-16-2020
14:20:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-16-2020
14:20:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000155
Page 113 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c
Date Location User Value Reason
Oct-16-2020
14:21:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Allergic
rhinitis
Start Date: UNK/U
NK/2000
Ongoing: YESInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000156
Page 114 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c Line/MH Number:
Date Location User Value Reason
Oct-16-2020
14:21:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020
14:21:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Allergic rhinitisInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-16-2020
14:21:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-16-2020
14:21:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000157
Page 115 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d
Date Location User Value Reason
Oct-16-2020
14:22:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Osteopor
osis
Start Date: UNK/U
NK/2019
Ongoing: YESInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000158
Page 116 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d Line/MH Number:
Date Location User Value Reason
Oct-16-2020
14:22:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020
14:22:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
OsteoporosisInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-16-2020
14:22:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-16-2020
14:22:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000159
Page 117 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-16-2020
14:22:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
The subject is NOT kn
own to be HIV POSIT
IVEInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000160
Page 118 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-16-2020
14:22:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-16-2020
14:22:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
76.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-16-2020
14:22:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-16-2020
14:22:48
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
155.0Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000161
Page 119 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
5. Unit:
Date Location User Value Reason
Oct-16-2020
14:22:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-16-2020
14:22:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
31.6Initial Entry
7.a
Date Location User Value Reason
Oct-16-2020
14:22:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.4
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000162
Page 120 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.a Record Identifier:
Date Location User Value Reason
Oct-16-2020
14:22:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-16-2020
14:22:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-16-2020
14:22:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-16-2020
14:22:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000163
Page 121 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-16-2020
14:23:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-16-2020
14:23:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-16-2020
14:23:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-16-2020
14:23:00
(UTC-03:00) CityACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000164
Page 122 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
5. Specimen Type:
Date Location User Value Reason
Oct-16-2020
14:23:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-16-2020
14:23:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogona
dotropin Be
ta_PX113
Result::
Not Done
::NOT DON
EInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-16-2020
14:23:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000165
Page 123 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
6.a Test:
Date Location User Value Reason
Oct-16-2020
14:23:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-16-2020
14:23:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000166
Page 124 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-16-2020
14:23:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/16/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-16-2020
14:23:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
270185Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000167
Page 125 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020
11:43:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020
11:43:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020
11:43:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020
11:43:28
(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
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000168
Page 126 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
appropriate.
Oct-19-2020
11:43:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020
11:43:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPTSX6Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020
11:43:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPTSX6Initial Entry
5.b
Date Location User Value Reason
Oct-19-2020
11:43:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BMM70
KInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000169
Page 127 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Sample ID
Date Location User Value Reason
Oct-19-2020
11:43:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BMM70KInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020
11:43:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BMM70
LInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020
11:43:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BMM70LInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000170
Page 128 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020
10:34:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020
10:34:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020
10:34:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020
10:34:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000171
Page 129 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
appropriate.
Oct-19-2020
10:34:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020
10:34:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BPTSW
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020
10:34:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPTSWZInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000172
Page 130 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-16-2020
14:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-16-2020
14:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-16-2020
14:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-16-2020
14:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/16/2020 13:32Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000173
Page 131 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5. Anatomical Location:
Date Location User Value Reason
Oct-16-2020
14:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-16-2020
14:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-16-2020
14:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-16-2020
14:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000174
Page 132 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
investigational product administration?
Date Location User Value Reason
Oct-16-2020
14:23:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000175
Page 133 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-16-2020
14:23:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000176
Page 134 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-05-2020
13:01:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/5/2020Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000177
Page 135 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Nov-05-2020
13:01:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/5/2020Initial Entry
2.a
Date Location User Value Reason
Nov-05-2020
13:01:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.2
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-05-2020
13:01:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000178
Page 136 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.a Temperature:
Date Location User Value Reason
Nov-05-2020
13:01:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
36.2Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-05-2020
13:01:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-05-2020
13:01:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000179
Page 137 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-05-2020
13:02:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-05-2020
13:02:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-05-2020
13:02:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/5/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-05-2020
13:02:20
(UTC-03:00) CityACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000180
Page 138 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
5. Specimen Type:
Date Location User Value Reason
Nov-05-2020
13:02:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-05-2020
13:02:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogona
dotropin Be
ta_PX113
Result::
Not Done
::NOT DON
EInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-05-2020
13:02:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000181
Page 139 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
6.a Test:
Date Location User Value Reason
Nov-05-2020
13:02:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Nov-05-2020
13:02:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000182
Page 140 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-05-2020
12:32:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-05-2020
12:32:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020
12:32:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-05-2020
12:32:20
(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
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000183
Page 141 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
appropriate.
Nov-05-2020
12:32:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
Nov-05-2020
12:32:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BR5TW
2Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-05-2020
12:32:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BR5TW2Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000184
Page 142 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-05-2020
13:02:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-05-2020
13:02:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-05-2020
13:02:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-05-2020
13:02:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/5/2020 12:00Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000185
Page 143 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5. Anatomical Location:
Date Location User Value Reason
Nov-05-2020
13:02:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-05-2020
13:02:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-05-2020
13:02:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-05-2020
13:02:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000186
Page 144 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
investigational product administration?
Date Location User Value Reason
Nov-05-2020
13:02:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000187
Page 145 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-03-2020
13:19:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/3/2020Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000188
Page 146 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-04-2020
08:55:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-04-2020
08:55:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-04-2020
08:55:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-04-2020
08:55:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000189
Page 147 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
appropriate.
Dec-04-2020
08:55:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/3/2020Initial Entry
5.a
Date Location User Value Reason
Dec-04-2020
08:55:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BR7C94Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-04-2020
08:55:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BR7C94Initial Entry
5.b
Date Location User Value Reason
Dec-04-2020
08:55:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BS2KCZInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000190
Page 148 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Sample ID
Date Location User Value Reason
Dec-04-2020
08:55:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BS2KCZInitial Entry
5.c
Date Location User Value Reason
Dec-04-2020
08:55:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BS2KD0Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-04-2020
08:55:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BS2KD0Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000191
Page 149 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-23-2020
03:56:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 3: Closed Closed as data
entered.
Dec-22-2020
10:54:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 3: Answered data updated
Dec-18-2020
08:11:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 3: Opened DM: Kindly
consider to
update missing
COVID TEST
form or else
clarify. Thank
you.
Dec-17-2020
16:28:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Dec-17-2020
10:13:27ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000192
Page 150 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos AiresDate of
Assessment in
the Signs and
Symptoms
form is
missing.
Please review
and update as
appropriate.
Dec-17-2020
10:13:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of
Collection in
both Nasal
Swab Self and
Nasal Swab
are missing.
Please review
and update as
appropriate.
Dec-17-2020
10:13:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/14/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-17-2020
10:13:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000193
Page 151 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/14/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/10/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-18-2021
10:01:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
Date of Last Sympt
om Resolved:
Dec/18/2020New
Information
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000194
Page 152 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.a
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: FEVE
R
Symptom Pre
sent:YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR IN
CREASED
COUGHInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000195
Page 153 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sympto
m Pres
ent:YES
4.b Symptoms:
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASE
D COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symp
toms:NEW OR INC
REASED SH
ORTNESS OF
BREATH
Symp
tom P
resen
t:YESInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000196
Page 154 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.c Symptoms:
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASE
D SHORTNESS OF B
REATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: CHIL
LS
Symptom Pre
sent:YESInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000197
Page 155 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.d Symptoms:
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE PA
IN
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000198
Page 156 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.e Symptoms:
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASE
D MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pre
sent:YESInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000199
Page 157 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.f Symptoms:
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW LOSS OF TAST
E OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.g
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THROA
T
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000200
Page 158 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.g Symptoms:
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASE
D SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: DIARR
HEA
Symptom P
resent:NOInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000201
Page 159 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.h Symptoms:
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: VOMIT
ING
Symptom P
resent:NOInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000202
Page 160 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.i Symptoms:
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Dec-17-2020
10:14:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Dec-17-2020
10:14:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms
- Other:Nasal obs
tructionInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Dec-17-2020
10:14:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Nasal obstructionInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000203
Page 161 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b
Date Location User Value Reason
Dec-17-2020
10:14:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms -
Other:Runny
noseInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Dec-17-2020
10:14:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Runny noseInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000204
Page 162 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Dec-22-2020
10:53:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000205
Page 163 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Dec-22-2020
10:53:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/12/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Dec-22-2020
10:53:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERI
ALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Dec-22-2020
10:53:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Dec-22-2020
10:53:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000206
Page 164 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5. Device Type:
Date Location User Value Reason
Dec-22-2020
10:53:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGN
OSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Dec-22-2020
10:53:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Dec-22-2020
10:53:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Dec-22-2020
10:53:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NALT unknownInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000207
Page 165 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020
10:16:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020
10:16:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020
10:16:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Dec-17-2020
10:16:09ACV0PFEINFP6000 Data Entry:
Subject used site swabInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000208
Page 166 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000209
Page 167 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020
16:28:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020
16:28:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020
16:28:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-17-2020
16:28:03
(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
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000210
Page 168 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
appropriate.
Dec-17-2020
16:28:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/14/2020Initial Entry
5.a
Date Location User Value Reason
Dec-17-2020
16:28:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BR796RInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-17-2020
16:28:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BR796RInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000211
Page 169 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Dec-17-2020
10:22:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Pract
itioner:SPEC
IALIS
T
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Pract
itioner:SPEC
IALIS
T
Occurrence o
f Visits or Co
ntacts:Initial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000212
Page 170 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Dec-17-2020
10:22:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of P
ractitione
r:EMERGE
NCY ROO
M
Occurren
ce of Visit
s or Cont
acts:YES
Number
of Visits
or Conta
cts:
1Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000213
Page 171 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Number of Visits or
Contacts:
1Initial Entry
1.c
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of P
ractitione
r:PRIMAR
Y CARE
PHYSICI
AN
Occurren
ce of Visit
s or Cont
acts:NOInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000214
Page 172 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
PRIMARY CARE PH
YSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Prac
titioner:URGE
NT CA
RE
Occurrence
of Visits or C
ontacts:NOInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000215
Page 173 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of P
ractitione
r:TELEPH
ONE CO
NSULTA
TION
Occurren
ce of Visit
s or Cont
acts:NOInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000216
Page 174 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
TELEPHONE CONS
ULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:OT
HE
R
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000217
Page 175 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Dec-17-2020
10:22:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Has the subject been
in intensive care due
to potential COVID-
19 illness?
NOInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000218
Page 176 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Dec-17-2020
10:23:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000219
Page 177 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HOSPITALIZATION DETAILS - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Dec-17-2020
10:23:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HOSPITALIZATION S
TATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Dec-17-2020
10:23:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
HOSPITALInitial Entry
3. Admission Date:
Date Location User Value Reason
Dec-17-2020
10:23:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/12/2020Initial Entry
4. Ongoing?
Date Location User Value Reason
Dec-17-2020
10:23:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000220
Page 178 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Dec-17-2020
10:24:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-1
9 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Jan-18-2021
10:06:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness
Diagnosis:
Viral pneumonia
Date of Diagnosis:
Jan/18/2021New
Information
Dec-17-2020
10:24:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000221
Page 179 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Dec-17-2020
10:24:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000222
Page 180 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/18/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-18-2021
10:06:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/18/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-18-2021
10:06:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000223
Page 181 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/18/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-18-2021
13:29:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-18-2021
13:29:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-18-2021
13:29:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/18/2021Transcription
Error
Jan-18-2021
13:29:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-18-2021 ACV0PFEINFP6000 auto query Query 1: Candidate 'Sample
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000224
Page 182 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/18/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13:29:34
(UTC-03:00) City
of Buenos Aires(autoquery) Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
appropriate.
Jan-18-2021
13:29:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
5.a
Date Location User Value Reason
Jan-18-2021
13:29:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BPTKN
2Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-18-2021
13:29:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPTKN2Initial Entry
5.b
Date Location User Value Reason
Jan-18-2021 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1000225
Page 183 of 199
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/18/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13:30:06
(UTC-03:00) City
of Buenos AiresSample ID: BRT73B
5.b Sample ID
Date Location User Value Reason
Jan-18-2021
13:30:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BRT73BInitial Entry
5.c
Date Location User Value Reason
Jan-18-2021
13:30:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRT73CInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-18-2021
13:30:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BRT73CInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000226
Page 184 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Jan-13-2021
09:44:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000227
Page 185 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Jan-13-2021
09:44:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-13-2021
09:44:41
(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
Jan-13-2021
09:44:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Respiratory Tract Vira
l infectionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-13-2021
15:23:16
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
Dec/10/2020 UNK:U
NKTranscription
Error
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000228
Page 186 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
Jan-13-2021
09:44:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/13/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-21-2021
09:42:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/18/2020 UNK
:UNKNew
Information
Jan-13-2021
09:44:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-13-2021
09:45:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000229
Page 187 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
Jan-15-2021
01:28:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-13-2021
09:44:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
Respiratory
Tract Viral
infection:
Response to
"Is the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Jan-13-2021
09:44:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event
associated with con
genital anomaly or
birth defect?
NO
Did this serious eve
nt result in death?Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000230
Page 188 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
NO
Did this serious eve
nt require or prolon
g hospitalization?
YES
Did this serious eve
nt result in persisten
t or significant disab
ility/incapacity?
NO
Is this serious event
life threatening?
NO
Other medically im
portant serious even
t
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.
Date Location User Value Reason
Jan-13-2021
09:44:41
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000231
Page 189 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-13-2021
09:44:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this ev
ent is due to:
OTHER
If Other, specify:
Viral infectionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-13-2021
09:44:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-13-2021
09:44:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000232
Page 190 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-13-2021
09:44:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Jan-22-2021
15:07:58
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Jan-21-2021
09:42:31
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query
2: Clo
sedClose Auto Query
Jan-21-2021
09:42:31
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dNew Information
Jan-21-2021
09:42:31
(UTC-03:00)ACV0PFEINFP6000 Data
Entry
:New Information
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000233
Page 191 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
City of
Buenos
AiresREC
OVE
RED/
RESO
LVE
D
Jan-21-2021
09:42:18
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query
2: Op
enedFor AE Respiratory Tract Viral
infection: Response to "What was
the outcome of this adverse event?"
is 'Recovering/Resolving' but AE
End Date/Time is present.
Jan-21-2021
01:53:38
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
1: Op
enedSAE
RECON:AER#2021017983,outcome
was reported as
RECOVERED/RESOLVED to
Safety DB however, recorded as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Jan-13-2021
15:23:35
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
REC
OVE
RING
/RES
OLVI
NGTranscription Error
Jan-13-2021 ACV0PFEINFP6000 DataInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1000234
Page 192 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
09:44:41
(UTC-03:00)
City of
Buenos
AiresEntry
:
NOT
REC
OVE
RED/
NOT
RESO
LVE
D
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-13-2021
09:44:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-15-2021
01:28:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
2021017983Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000235
Page 193 of 199
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-03-2020
13:19:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-03-2020
13:19:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-03-2020
13:19:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000236
Page 194 of 199
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-27-2021
15:06:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/27/2021Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000237
Page 195 of 199
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-27-2021
15:06:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing
to return for Vaccina
tion 3
Participant is:
eligible and NOT
confirmed to hav
e received only pl
acebo at Vaccinat
ion 1/2Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000238
Page 196 of 199
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-27-2021
15:06:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/27/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-27-2021
15:06:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000239
Page 197 of 199
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-03-2020
13:19:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-16-2020
14:23:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Oct-16-2020
14:19:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-15-2021
01:29:02
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Clo
sedResponse satisfies query
Jan-13-2021
09:45:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: An
swereddata updated
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000240
Page 198 of 199
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Jan-13-2021
09:00:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Op
enedSAE
RECON:AER#2021017983
Respiratory tract viral
infection(onset
date:13Dec2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Dec-03-2020
13:19:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/3/2020Initial Entry
Oct-16-2020
14:23:15
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/16/2020Initial Entry
Oct-16-2020
14:19:01
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/16/2020Initial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1000241
Page 199 of 199
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412263 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Casebook Signature
Date Location User Value Reason
Jan-21-2021
17:52:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3f7a\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1000242