125742 S1 M5 CRF c4591001 1226 12261599

Document text

Page 1 of 409
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851431
Page 2 of 409
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/7/2020
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851432
Page 3 of 409
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12261599]
2.Birth Date: /1979
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851433
Page 4 of 409
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/7/2020
2.Erroneous Visit
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851434
Page 5 of 409
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years,
inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use only) IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits, vaccination plan,
laboratory tests, lifestyle considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer use only) IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical examination, and
clinical judgment of the investigator to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use only) IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance with the
requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use only) IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active suicidal
ideation/behavior/lab abnormality that may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851435
Page 6 of 409
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction
(eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as determined
by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion
of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or systemic
corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851436
Page 7 of 409
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention
administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to study entry
and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing lipid
nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the study, site
staff otherwise supervised by the investigator, and their respective family members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851437
Page 8 of 409
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851438
Page 9 of 409
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[headache]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Albright's osteodystrophy]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851439
Page 10 of 409
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/7/2020
2.Weight: [71.3]
3.Unit: kg
4.Height: [160.9]
5.Unit: cm
6.Body Mass Index: [27.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: FOREHEAD
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851440
Page 11 of 409
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/7/2020
4.Laboratory Name and Address (Derived) [STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851441
Page 12 of 409
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/7/2020
2.Randomization Number: [83114]
3.Randomization Group: [ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851442
Page 13 of 409
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/7/2020
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 [BPTJVP]
5.bSample ID [BPTJVR]
5.cSample ID [BPTJVS]
5.dSample ID [BPHNYH]
5.eSample ID [BPHNYJ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851443
Page 14 of 409
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/7/2020
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 [BPTJVB]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851444
Page 15 of 409
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/7/2020 13:18
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851445
Page 16 of 409
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851446
Page 17 of 409
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851447
Page 18 of 409
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Oct/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851448
Page 19 of 409
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/2/2020
4.Laboratory Name and Address (Derived) [STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851449
Page 20 of 409
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/2/2020
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 [BPVYTX]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851450
Page 21 of 409
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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/2/2020 13:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851451
Page 22 of 409
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851452
Page 23 of 409
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/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 [BR78CT]
5.bSample ID [BS2VC9]
5.cSample ID [BS2VCB]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851453
Page 24 of 409
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851454
Page 25 of 409
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851455
Page 26 of 409
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851456
Page 27 of 409
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851457
Page 28 of 409
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851458
Page 29 of 409
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851459
Page 30 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/7/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851460
Page 31 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/7/2020
2.Date of First Symptom Started: Nov/6/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/13/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Coryza]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851461
Page 32 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Coll
ectionSpecimen TypeSpecimen Collectio
n LocationAssay Code and Description Device TypeForm Instanc
e
 1.Nov/7/2020  SWABBED MA
TERIAL NASOPHARYNX  SEVERE ACUTE RESP SYNDROM
E CORONAVIRUS 2 SARS-COV-2 DIAGN
OSTIC TEST Repeating
Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851462
Page 33 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/7/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: POSITIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [NALT Unknown] Comments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851463
Page 34 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
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 [RW91559]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851464
Page 35 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/7/2020
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 [BR6946]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851465
Page 36 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare Professional: SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare Professional: EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare Professional: PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare Professional: URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare Professional: TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare Professional: OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due to
potential COVID-19 illness?NO
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851466
Page 37 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicable
 Not Applicable
 Not Applicable
 Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851467
Page 38 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851468
Page 39 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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:
[COVID-19]
Date of Diagnosis:
Nov/7/2020
3.Toxicity Grade: 2
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851469
Page 40 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851470
Page 41 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851471
Page 42 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.Not Applicable  Not Applica
ble Not Applicab
le Not Applica
ble Sponsor-Defined Ide
ntifierTest: Result:
Not Applicable  Not Applica
ble Not Applica
ble 
Not Applicable  Not Applica
ble Not Applica
ble 
Not Applicable  Not Applica
ble Not Applica
ble 
Not Applicable  Not Applica
ble Not Applica
ble 
Not Applicable  Not Applica
ble Not Applica
ble 
Not Applicable  Not Applica
ble Not Applica
ble 
Not Applicable  Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851472
Page 43 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851473
Page 44 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851474
Page 45 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851475
Page 46 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851476
Page 47 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for La
b TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applic
able Sponsor-Defined Id
entifierTest: Result:
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able Repeating
Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851477
Page 48 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851478
Page 49 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851479
Page 50 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851480
Page 51 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851481
Page 52 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851482
Page 53 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851483
Page 54 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Nov/7/2020 Record Identifier: Systolic: Diastolic:
1  133  92 Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851484
Page 55 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [133]
Diastolic: [92]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [89]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851485
Page 56 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Nov/7/2020 Record Identifier: Oxygen Saturation
1  93.0 Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851486
Page 57 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/7/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [93.0]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851487
Page 58 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851488
Page 59 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851489
Page 60 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Iden
tifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applicab
le Repeating
Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851490
Page 61 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications Pre-specified: Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851491
Page 62 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851492
Page 63 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851493
Page 64 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/6/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851494
Page 65 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/6/2021
2.Date of First Symptom Started: Feb/4/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Runny nose]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851495
Page 66 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locatio
nAssay Code and Descriptio
nDevice Type Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851496
Page 67 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851497
Page 68 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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:[Collected on site, recorded at SWAB PFE]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851498
Page 69 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/6/2021
4.If no sample was collected or sample was
not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRH04K]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851499
Page 70 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare Professional: SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare Professional: EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare Professional: PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare Professional: URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare Professional: TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare Professional: OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due to
potential COVID-19 illness?NO
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851500
Page 71 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851501
Page 72 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851502
Page 73 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851503
Page 74 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851504
Page 75 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851505
Page 76 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for Lab Te
stVendor Nam
eCollection Dat
e:Specimen Typ
eLab Result Form Instance
 1.       Sponsor-Defined Identifi
erTest
:Result
:Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851506
Page 77 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851507
Page 78 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for Lab
TestVendor Name (DERI
VED)Collection Da
te:Specimen Ty
peLab Result Form Instance
 1.       Sponsor-Defined Iden
tifierTest
:Resul
t:Repeating
Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851508
Page 79 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851509
Page 80 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Feb/6/2021 Record Identifier: Systolic: Diastolic:
1  139  93 Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851510
Page 81 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/6/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [139]
Diastolic: [93]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [78]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851511
Page 82 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Feb/6/2021 Record Identifier: Oxygen Saturation
1  99.0 Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851512
Page 83 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/6/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851513
Page 84 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851514
Page 85 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851515
Page 86 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Identi
fierCategory for Medicat
ionConcomitant Medications Pre-spe
cifiedName of Medicati
onStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851516
Page 87 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851517
Page 88 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851518
Page 89 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851519
Page 90 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Dec/15/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851520
Page 91 of 409
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Dec/15/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/15/2020
4.If no sample was collected or sample was
not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGTHM]
5.bSample ID [BSF217]
5.cSample ID [BSF21D]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851521
Page 92 of 409
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on Sep/08/2020 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851522
Page 93 of 409
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on Sep/08/2020 Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851523
Page 94 of 409
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on Sep/08/2020 Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Sep/8/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Contact made due to covid-19 symptom alert. Patient refers muscle pain on 07Sep2020
(grade1), related to vaccine reactogenicity.]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851524
Page 95 of 409
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851525
Page 96 of 409
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851526
Page 97 of 409
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851527
Page 98 of 409
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851528
Page 99 of 409
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851529
Page 100 of 409
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851530
Page 101 of 409
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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:
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851531
Page 102 of 409
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851532
Page 103 of 409
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851533
Page 104 of 409
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851534
Page 105 of 409
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851535
Page 106 of 409
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851536
Page 107 of 409
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851537
Page 108 of 409
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851538
Page 109 of 409
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851539
Page 110 of 409
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851540
Page 111 of 409
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Identifie
rAdverse Event Start DateIs the Adverse Event Still Ongoi
ngForm Instance
 1.ADVERSE EVEN
T 1  myalgia  Sep/7/2020 20:00  NO
End Date Time:
Sep/10/2020 UNK:UNK
 Repeating Pages
 2.ADVERSE EVEN
T 2  fatigue  Sep/7/2020 20:00  NO
End Date Time:
Sep/10/2020 UNK:UNK
 Repeating Pages
 3.ADVERSE EVEN
T 3  corneal ulcer right ey
e Sep/20/2020 UNK:UN
K NO
End Date Time:
Sep/27/2020 UNK:UNK
 Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851541
Page 112 of 409
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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)[myalgia]
4.Start Date Time: Sep/7/2020 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/10/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
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[ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851542
Page 113 of 409
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[fatigue]
4.Start Date Time: Sep/7/2020 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/10/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851543
Page 114 of 409
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[corneal ulcer right eye]
4.Start Date Time: Sep/20/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/27/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).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:
[prolonged use of contact lens]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
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
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851544
Page 115 of 409
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851545
Page 116 of 409
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoin
gStudy Medication Errors Actio
nForm Instance
 1.          Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851546
Page 117 of 409
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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[ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851547
Page 118 of 409
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Identi
fierCategory for Medicat
ionConcomitant Medications Pre-spe
cifiedName of Medicati
onStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851548
Page 119 of 409
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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: //
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851549
Page 120 of 409
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Iden
tifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionDose Descript
ionForm Instance
 1.          Repeating
Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851550
Page 121 of 409
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851551
Page 122 of 409
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851552
Page 123 of 409
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851553
Page 124 of 409
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
 1.     Repeating Pages
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851554
Page 125 of 409
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851555
Page 126 of 409
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851556
Page 127 of 409
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Booster Dose Trigger Form
1.Select appropriate response - Will the
participant return for consent/eligibility
assessment for the booster dose visit?
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851557
Page 128 of 409
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/5/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851558
Page 129 of 409
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851559
Page 130 of 409
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851560
Page 131 of 409
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/3/2020
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851561
Page 132 of 409
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851562
Page 133 of 409
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Cristiano Zerbini  Approved Feb-11-2021 17:33:50 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, 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.
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851563
Page 134 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormNov-11-2020 15:59:50 (UTC-03:00) City of Buenos
Aires
FormNov-07-2020 12:53:38 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851564
Page 135 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Nov-11-2020 15:59:50 (UTC-03:00) City of Buenos
Aires
1Nov-07-2020 12:53:38 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851565
Page 136 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Nov-11-2020 15:59:50 (UTC-03:00) City of Buenos
Aires
2Nov-07-2020 12:53:38 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851566
Page 137 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Nov-11-2020 15:59:50 (UTC-03:00) City of Buenos
Aires
3Nov-07-2020 12:53:38 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851567
Page 138 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Nov-11-2020 15:59:50 (UTC-03:00) City of Buenos
Aires
4Nov-07-2020 12:53:38 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851568
Page 139 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Nov-11-2020 15:59:50 (UTC-03:00) City of Buenos
Aires
5Nov-07-2020 12:53:38 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851569
Page 140 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Nov-11-2020 15:59:50 (UTC-03:00) City of Buenos
Aires
6Nov-07-2020 12:53:38 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851570
Page 141 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
7Nov-11-2020 15:59:50 (UTC-03:00) City of Buenos
Aires
7Nov-07-2020 12:53:38 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851571
Page 142 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
8Nov-11-2020 15:59:50 (UTC-03:00) City of Buenos
Aires
8Nov-07-2020 12:53:38 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851572
Page 143 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
9Nov-11-2020 15:59:50 (UTC-03:00) City of Buenos
Aires
9Nov-07-2020 12:53:38 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851573
Page 144 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormNov-07-2020 12:54:08 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851574
Page 145 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Nov-07-2020 12:54:08 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851575
Page 146 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Nov-07-2020 12:54:08 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851576
Page 147 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Nov-07-2020 12:54:08 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851577
Page 148 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Nov-07-2020 12:54:08 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851578
Page 149 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Nov-07-2020 12:54:08 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851579
Page 150 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Nov-07-2020 12:54:08 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851580
Page 151 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormNov-07-2020 12:54:40 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851581
Page 152 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Nov-07-2020 12:54:40 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851582
Page 153 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Nov-07-2020 12:54:40 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851583
Page 154 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Nov-07-2020 12:54:40 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851584
Page 155 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Nov-07-2020 12:54:40 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851585
Page 156 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851586
Page 157 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Nov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851587
Page 158 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Nov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851588
Page 159 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Nov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851589
Page 160 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Nov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851590
Page 161 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851591
Page 162 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851592
Page 163 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851593
Page 164 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851594
Page 165 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851595
Page 166 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851596
Page 167 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851597
Page 168 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851598
Page 169 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851599
Page 170 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851600
Page 171 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851601
Page 172 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851602
Page 173 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851603
Page 174 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851604
Page 175 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851605
Page 176 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851606
Page 177 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851607
Page 178 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851608
Page 179 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851609
Page 180 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851610
Page 181 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851611
Page 182 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851612
Page 183 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851613
Page 184 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851614
Page 185 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851615
Page 186 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851616
Page 187 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851617
Page 188 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gNov-07-2020 12:54:54 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851618
Page 189 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851619
Page 190 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Nov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851620
Page 191 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Nov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851621
Page 192 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Nov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851622
Page 193 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Nov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851623
Page 194 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851624
Page 195 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851625
Page 196 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851626
Page 197 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851627
Page 198 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851628
Page 199 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851629
Page 200 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851630
Page 201 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851631
Page 202 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851632
Page 203 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851633
Page 204 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851634
Page 205 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851635
Page 206 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851636
Page 207 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851637
Page 208 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851638
Page 209 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851639
Page 210 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851640
Page 211 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851641
Page 212 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851642
Page 213 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851643
Page 214 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851644
Page 215 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851645
Page 216 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851646
Page 217 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851647
Page 218 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851648
Page 219 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851649
Page 220 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851650
Page 221 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851651
Page 222 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.hNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851652
Page 223 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.hNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851653
Page 224 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.hNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851654
Page 225 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.hNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851655
Page 226 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.iNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851656
Page 227 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.iNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851657
Page 228 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.iNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851658
Page 229 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.iNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851659
Page 230 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.jNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851660
Page 231 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.jNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851661
Page 232 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.jNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851662
Page 233 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.jNov-07-2020 12:55:16 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851663
Page 234 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormNov-07-2020 12:58:10 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851664
Page 235 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Nov-07-2020 12:58:10 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851665
Page 236 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Nov-07-2020 12:58:10 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851666
Page 237 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Nov-07-2020 12:58:10 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851667
Page 238 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormNov-07-2020 12:58:23 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851668
Page 239 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Nov-07-2020 12:58:23 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851669
Page 240 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Nov-07-2020 12:58:23 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851670
Page 241 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Nov-07-2020 12:58:23 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851671
Page 242 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Nov-07-2020 12:58:23 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851672
Page 243 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Nov-07-2020 12:58:23 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851673
Page 244 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Nov-07-2020 12:58:23 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851674
Page 245 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormNov-07-2020 12:58:55 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851675
Page 246 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Nov-07-2020 12:58:55 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851676
Page 247 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Nov-07-2020 12:58:55 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851677
Page 248 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Nov-07-2020 12:58:55 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851678
Page 249 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/07/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Nov-07-2020 12:58:55 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851679
Page 250 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormFeb-08-2021 08:25:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851680
Page 251 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Feb-08-2021 08:25:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851681
Page 252 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Feb-08-2021 08:25:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851682
Page 253 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Feb-08-2021 08:25:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851683
Page 254 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Feb-08-2021 08:25:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851684
Page 255 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Feb-08-2021 08:25:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851685
Page 256 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Feb-08-2021 08:25:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851686
Page 257 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
7Feb-08-2021 08:25:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851687
Page 258 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
8Feb-08-2021 08:25:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851688
Page 259 of 409
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Feb/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
9Feb-08-2021 08:25:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0851689
Page 260 of 409
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Cristiano Zerbini  Approved Feb-11-2021 17:33:50 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be
the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-08-2021 08:24:08 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Jan-21-2021 16:50:53 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be
the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-15-2020 16:46:07 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Nov-16-2020 09:29:09 (UTC-03:00) City of Buenos
AiresBOOK Signed
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851690
Page 261 of 409
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be
the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-16-2020 08:00:34 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Nov-15-2020 09:47:47 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be
the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-13-2020 15:30:55 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Nov-11-2020 21:53:20 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be
the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-07-2020 12:51:41 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851691
Page 262 of 409
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Cristiano Zerbini  Approved Nov-06-2020 15:39:20 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, 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.
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0851692
Page 263 of 409
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-07-2020 15:42:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-07-2020 15:42:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851693
Page 264 of 409
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-07-2020 15:42:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/7/2020Initial Entry
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851694
Page 265 of 409
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-07-2020 15:42:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12261599Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-07-2020 15:42:00
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1979Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-07-2020 15:42:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-07-2020 15:42:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OF SPA
NISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-07-2020 15:42:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851695
Page 266 of 409
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-07-2020 15:42:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/7/2020Initial Entry
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851696
Page 267 of 409
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Sep-07-2020 15:43:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants betw
een the ages of 18 and 55 years,
inclusive, 65 and 85 years, inclu
sive, or 18 and 85 years, inclusiv
e, at randomization (dependent u
pon study stage)
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Sep-07-2020 15:43:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Sep-07-2020 15:43:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Male or female participants between the a
ges of 18 and 55 years, inclusive, 65 and 8
5 years, inclusive, or 18 and 85 years, incl
usive, at randomization (dependent upon s
tudy stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Sep-07-2020 15:43:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae405d\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0851697
Page 268 of 409
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261599 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-07-2020 15:
…[truncated]