125742 S1 M5 CRF c4591001 1226 12261836

Document text

Page 1 of 277
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853739
Page 2 of 277
***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: 12261836 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/18/2020
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853740
Page 3 of 277
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12261836]
2.Birth Date: 1980
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0853741
Page 4 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853742
Page 5 of 277
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 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: 12261836 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853743
Page 6 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853744
Page 7 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853745
Page 8 of 277
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853746
Page 9 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853747
Page 10 of 277
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
2.Weight: [74.2]
3.Unit: kg
4.Height: [162.5]
5.Unit: cm
6.Body Mass Index: [28.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853748
Page 11 of 277
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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/18/2020
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:
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853749
Page 12 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/18/2020
2.Randomization Number: [93367]
3.Randomization Group: [ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853750
Page 13 of 277
***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: 12261836 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/18/2020
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 [BP7WVJ]
5.bSample ID [BP7WVH]
5.cSample ID [BP7WVG]
5.dSample ID [BRXVYY]
5.eSample ID [BRXVYX]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853751
Page 14 of 277
***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: 12261836 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/18/2020
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 [BP7WZ9]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853752
Page 15 of 277
***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: 12261836 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/18/2020 11:44
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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853753
Page 16 of 277
***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: 12261836 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853754
Page 17 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853755
Page 18 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Oct/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853756
Page 19 of 277
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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/9/2020
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:
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853757
Page 20 of 277
***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: 12261836 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/9/2020
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 [BPWZFJ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853758
Page 21 of 277
***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: 12261836 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/9/2020 13:09
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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853759
Page 22 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853760
Page 23 of 277
***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: 12261836 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/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 [BR697J]
5.bSample ID [BS2XJY]
5.cSample ID [BS2XJX]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853761
Page 24 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853762
Page 25 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/16/2020
2.Date of First Symptom Started: Dec/10/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/1/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
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? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Increased body temperature 37.8 C]
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(b) (4)
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Page 26 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Col
lectionSpecimen TypeSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
 1.Dec/11/202
0 SWABBED MA
TERIAL NASOPHARYNX  SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAGN
OSTIC TEST Repeating
Pages
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853764
Page 27 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 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: Dec/11/2020 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: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [NALT Unknown] Comments
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(b) (4)
FDA-CBER-2021-5683-0853765
Page 28 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 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:[The collection was made in site.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
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(b) (4)
FDA-CBER-2021-5683-0853766
Page 29 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 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:
Dec/16/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGTJR]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853767
Page 30 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853768
Page 31 of 277
***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: 12261836 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853769
Page 32 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 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?
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853770
Page 33 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853771
Page 34 of 277
***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: 12261836 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853772
Page 35 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 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:
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853773
Page 36 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for Lab T
estVendor Na
meCollection Dat
e:Specimen Ty
peLab Result Form Instance
 1.       Sponsor-Defined Identi
fierTest
:Result
:Repeating
Pages
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853774
Page 37 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853775
Page 38 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for Lab
TestVendor Name (DERI
VED)Collection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853776
Page 39 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-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: 12261836 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853777
Page 40 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Dec/16/2020 Record Identifier: Systolic: Diastolic:
1  125  75 Repeating Pages
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853778
Page 41 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-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: 12261836 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: Dec/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [125]
Diastolic: [75]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [94]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853779
Page 42 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Dec/16/2020 Record Identifier: Oxygen Saturation
1  99.0 Repeating Pages
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853780
Page 43 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-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: 12261836 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: Dec/16/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853781
Page 44 of 277
***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: 12261836 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853782
Page 45 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 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): [ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853783
Page 46 of 277
***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: 12261836 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 Da
teForm Instance
 1.          Repeating
Pages
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853784
Page 47 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 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?
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853785
Page 48 of 277
***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: 12261836 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853786
Page 49 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 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:
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853787
Page 50 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Jan/13/2021Form: 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853788
Page 51 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Jan/13/2021Form: 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: 12261836 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:
Jan/13/2021
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 [BP994W]
5.bSample ID [BSF2F1]
5.cSample ID [BSF2F2]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853789
Page 52 of 277
***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: 12261836 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:
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853790
Page 53 of 277
***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: 12261836 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 [ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853791
Page 54 of 277
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853792
Page 55 of 277
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853793
Page 56 of 277
***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: 12261836 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/11/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853794
Page 57 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853795
Page 58 of 277
***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: 12261836 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:
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853796
Page 59 of 277
***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: 12261836 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:
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853797
Page 60 of 277
***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: 12261836 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?
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853798
Page 61 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853799
Page 62 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853800
Page 63 of 277
***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: 12261836 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: [ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853801
Page 64 of 277
***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, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853802
Page 65 of 277
***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, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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 per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853803
Page 66 of 277
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/23/2021
2.Erroneous Visit
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853804
Page 67 of 277
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/23/2021
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853805
Page 68 of 277
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853806
Page 69 of 277
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/23/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853807
Page 70 of 277
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 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: 12261836 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: Jan/23/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853808
Page 71 of 277
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 12261836 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:
Jan/23/2021
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 [BR67XZ]
5.bSample ID [BSF1LL]
5.cSample ID [BSF1LM]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853809
Page 72 of 277
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 12261836 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:
Jan/23/2021
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 [BR67WW]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853810
Page 73 of 277
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 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: 12261836 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/23/2021 14:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853811
Page 74 of 277
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/15/2021
2.Erroneous Visit
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853812
Page 75 of 277
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 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: 12261836 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: Feb/15/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853813
Page 76 of 277
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12261836 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/15/2021
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 [BRJRZV]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853814
Page 77 of 277
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 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: 12261836 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/15/2021 14:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853815
Page 78 of 277
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/15/2021
2.Erroneous Visit
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853816
Page 79 of 277
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 12261836 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:
Mar/15/2021
3.Comments: [ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853817
Page 80 of 277
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853818
Page 81 of 277
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853819
Page 82 of 277
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853820
Page 83 of 277
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853821
Page 84 of 277
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Mar/15/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853822
Page 85 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1  Supraventricular tachyc
ardia Feb/11/2021 UNK:UN
K NO
End Date Time:
Feb/11/2021 UNK:UNK
 Repeating
Pages
 2.ADVERSE EVE
NT 2  Muscle pain  Feb/12/2021 UNK:UN
K NO
End Date Time:
Feb/13/2021 UNK:UNK
 Repeating
Pages
 3.ADVERSE EVE
NT 3  gastroesophageal reflux  Nov/UNK/2020 UNK:
UNK YES  Repeating
Pages
 4.ADVERSE EVE
NT 4  Fatigue  Jan/24/2021 UNK:UN
K NO
End Date Time:
Jan/25/2021 UNK:UNK
 Repeating
Pages
 5.ADVERSE EVE
NT 5  Anxiety  Nov/10/2020 UNK:UN
K YES  Repeating
Pages
 6.ADVERSE EVE
NT 6  automobile accident (dri
ver) Feb/11/2021 UNK:UN
K NO
End Date Time:
Feb/11/2021 UNK:UNK
 Repeating
Pages
 7.ADVERSE EVE
NT 7  Loss of consciousness  Feb/11/2021 UNK:UN
K NO
End Date Time:
Feb/11/2021 UNK:UNK
 Repeating
Pages
 8.ADVERSE EVE
NT 8  pain at the injection site  Feb/16/2021 UNK:UN
K NO
End Date Time:
Feb/18/2021 UNK:UNK
 Repeating
Pages
 9.ADVERSE EVE
NT 9  fever (37,8 C)  Feb/16/2021 UNK:UN
K NO
End Date Time:
Feb/18/2021 UNK:UNK
 Repeating
Pages
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853823
Page 86 of 277
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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)[Supraventricular tachycardia]
4.Start Date Time: Feb/11/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/11/2021 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:
[unknown]
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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853824
Page 87 of 277
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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[ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853825
Page 88 of 277
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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)[Muscle pain]
4.Start Date Time: Feb/12/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/13/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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:
[Car accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853826
Page 89 of 277
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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[2021161303]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853827
Page 90 of 277
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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)[gastroesophageal reflux]
4.Start Date Time: Nov/UNK/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
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: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN]
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?:RECOVERING/RESOLVING
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853828
Page 91 of 277
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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[ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853829
Page 92 of 277
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fatigue]
4.Start Date Time: Jan/24/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/25/2021 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853830
Page 93 of 277
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853831
Page 94 of 277
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Anxiety]
4.Start Date Time: Nov/10/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
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:
[over-worrying about work]
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?:RECOVERING/RESOLVING
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853832
Page 95 of 277
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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[ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853833
Page 96 of 277
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[automobile accident (driver)]
4.Start Date Time: Feb/11/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/11/2021 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:
[supraventricular tachycardia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853834
Page 97 of 277
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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[ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853835
Page 98 of 277
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Loss of consciousness]
4.Start Date Time: Feb/11/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/11/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).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:
[supraventricular tachycardia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853836
Page 99 of 277
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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[ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853837
Page 100 of 277
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[pain at the injection site]
4.Start Date Time: Feb/16/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/18/2021 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853838
Page 101 of 277
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853839
Page 102 of 277
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[fever (37,8 C)]
4.Start Date Time: Feb/16/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/18/2021 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853840
Page 103 of 277
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853841
Page 104 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Acti
onForm Instance
 1.          Repeating Pages
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853842
Page 105 of 277
***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: 12261836 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[ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853843
Page 106 of 277
***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: 12261836 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 Da
teForm Instance
 1.          Repeating
Pages
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853844
Page 107 of 277
***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: 12261836 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: //
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853845
Page 108 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionDose Descrip
tionForm Instance
 1.          Repeating
Pages
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853846
Page 109 of 277
***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: 12261836 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?
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853847
Page 110 of 277
***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: 12261836 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853848
Page 111 of 277
***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: 12261836 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?
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853849
Page 112 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
 1.     Repeating Pages
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853850
Page 113 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853851
Page 114 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/22/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853852
Page 115 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853853
Page 116 of 277
***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: 12261836 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: [ ]
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853854
Page 117 of 277
***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: 12261836 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/11/2020
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853855
Page 118 of 277
***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: 12261836 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
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853856
Page 119 of 277
***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: 12261836 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 Mar-16-2021 11:46:59 (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.
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853857
Page 120 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-18-2020 15:14:31 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0853858
Page 121 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormDec-17-2020 11:59:58 (UTC-03:00) City of Buenos
Aires
FormDec-17-2020 07:21:55 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853859
Page 122 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Dec-17-2020 11:59:58 (UTC-03:00) City of Buenos
Aires
1Dec-17-2020 07:21:55 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853860
Page 123 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Dec-17-2020 11:59:58 (UTC-03:00) City of Buenos
Aires
2Dec-17-2020 07:21:55 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853861
Page 124 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Dec-17-2020 11:59:58 (UTC-03:00) City of Buenos
Aires
3Dec-17-2020 07:21:55 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853862
Page 125 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Dec-17-2020 11:59:58 (UTC-03:00) City of Buenos
Aires
4Dec-17-2020 07:21:55 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853863
Page 126 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Dec-17-2020 11:59:58 (UTC-03:00) City of Buenos
Aires
5Dec-17-2020 07:21:55 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0853864
Page 127 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Dec-17-2020 11:59:58 (UTC-03:00) City of Buenos
Aires
6Dec-17-2020 07:21:55 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853865
Page 128 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
7Dec-17-2020 11:59:58 (UTC-03:00) City of Buenos
Aires
7Dec-17-2020 07:21:55 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853866
Page 129 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
8Dec-17-2020 11:59:58 (UTC-03:00) City of Buenos
Aires
8Dec-17-2020 07:21:55 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853867
Page 130 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
9Dec-17-2020 11:59:58 (UTC-03:00) City of Buenos
Aires
9Dec-17-2020 07:21:55 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853868
Page 131 of 277
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormJan-23-2021 15:40:18 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853869
Page 132 of 277
***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: 12261836 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 Mar-16-2021 11:46:59 (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 Mar-15-2021 13:30:12 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Mar-12-2021 09:32:21 (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 Mar-10-2021 15:29:55 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Mar-10-2021 14:50:30 (UTC-03:00) City of Buenos
AiresBOOK Signed
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0853870
Page 133 of 277
***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: 12261836 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 Mar-08-2021 10:53:15 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Mar-04-2021 10:11:35 (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-17-2021 15:26:14 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Feb-17-2021 08:33:24 (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-15-2021 16:04:59 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (6)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0853871
Page 134 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
N/A
Cristiano Zerbini  Approved Feb-12-2021 10:32:54 (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 Jan-23-2021 15:39:13 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Jan-21-2021 17:39:24 (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-17-2020 07:16:28 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano Zerbini  Approved Nov-11-2020 22:41:33 (UTC-03:00) City of Buenos
AiresBOOK Signed
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0853872
Page 135 of 277
***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: 12261836 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.
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0853873
Page 136 of 277
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 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-18-2020 15:13:11
(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-18-2020 15:13:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853874
Page 137 of 277
***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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-18-2020 15:13:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/18/2020Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853875
Page 138 of 277
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-18-2020 15:08:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12261836Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-18-2020 15:07:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1980Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-18-2020 15:13:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-18-2020 15:13:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OF SP
ANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-18-2020 15:13:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853876
Page 139 of 277
***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: 12261836 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-18-2020 15:13:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853877
Page 140 of 277
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants bet
ween the ages of 18 and 55 yea
rs, inclusive, 65 and 85 years, i
nclusive, or 18 and 85 years, in
clusive, at randomization (depe
ndent upon study stage)
Criteri
on met
?YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Male or female participants between the
ages of 18 and 55 years, inclusive, 65 an
d 85 years, inclusive, or 18 and 85 years,
inclusive, at randomization (dependent u
pon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853878
Page 141 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aires
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusio
n Num
ber:2
Criteri
on Desc
ription:Participants who are willing a
nd able to comply with all sch
eduled visits, vaccination plan
, laboratory tests, lifestyle con
siderations, and other study pr
ocedures
Criteri
on met?
:YES
Criteri
on ID: (
For Pfi
zer use
only):IN02A00Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853879
Page 142 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Inclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participants who are willing and able to
comply with all scheduled visits, vaccin
ation plan, laboratory tests, lifestyle con
siderations, and other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Desc
ription:Healthy participants who are d
etermined by medical history,
physical examination, and clin
ical judgment of the investigat
or to be eligible for inclusion i
n the studyInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853880
Page 143 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on met
?:YES
Criteri
on ID: (
For Pfi
zer use
only):IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Healthy participants who are determined
by medical history, physical examinatio
n, and clinical judgment of the investigat
or to be eligible for inclusion in the stud
yInitial Entry
1.c Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry:
Inclusio4Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853881
Page 144 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aires n Numb
er:
Criterio
n Descr
iption:Capable of giving personal sig
ned informed consent, which i
ncludes compliance with the r
equirements and restrictions li
sted in the ICD and in this pro
tocol
Criterio
n met?:YES
Criterio
n ID: (F
or Pfize
r use on
ly):IN04A00
1.d Inclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Capable of giving personal signed infor
med consent, which includes complianc
e with the requirements and restrictions l
isted in the ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853882
Page 145 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.a
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:1
Criteri
on Desc
ription:Other medical or psychiatric c
ondition incl. recent (within pa
st year) or active suicidal ideat
ion/behavior/lab abnormality t
hat may increase the risk of stu
dy participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX01A00Initial Entry
2.a Exclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Other medical or psychiatric condition i
ncl. recent (within past year) or active su
icidal ideation/behavior/lab abnormality
that may increase the risk of study partic
ipationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853883
Page 146 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:2
Criterion
Descripti
on:Known infection with huma
n immunodeficiency virus (
HIV), hepatitis C virus (HC
V), or hepatitis B virus (HB
V)
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX02A00Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853884
Page 147 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.b Exclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Known infection with human immunode
ficiency virus (HIV), hepatitis C virus (
HCV), or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:3
Criterio
n Descr
iption:History of severe adverse reac
tion associated with a vaccine
and/or severe allergic reaction
(eg, anaphylaxis) to any comp
onent of the study interventio
n(s)
Criterio
n met?:NOInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853885
Page 148 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterio
n ID: (F
or Pfize
r use on
ly):EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
History of severe adverse reaction associ
ated with a vaccine and/or severe allergi
c reaction (eg, anaphylaxis) to any comp
onent of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:4
Criterion Desc
ription:Receipt of medications
intended to prevent C
OVID-19Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853886
Page 149 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Receipt of medications intended to prev
ent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:8Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0853887
Page 150 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterio
n Descri
ption:Immunocompromised individ
uals with known or suspected
immunodeficiency, as determi
ned by history and/or laborato
ry/physical examination
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Immunocompromised individuals with k
nown or suspected immunodeficiency, a
s determined by history and/or laborator
y/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853888
Page 151 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:10
Criterio
n Descri
ption:Bleeding diathesis or conditio
n associated with prolonged b
leeding that would, in the opi
nion of the investigator, contr
aindicate intramuscular injecti
on
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX10A00Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0853889
Page 152 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.f Exclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition associate
d with prolonged bleeding that would, in
the opinion of the investigator, contraind
icate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion Numb
er:11
Criterion Descri
ption:Women who are pre
gnant or breastfeedi
ng
Criterion met?: NO
Criterion ID: (Fo
r Pfizer use only)
:EX11A00Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853890
Page 153 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.g Exclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Women who are pregnant or breastfeedi
ngInitial Entry
2.g Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion Num
ber:12
Criterion Descr
iption:Previous vaccination
with any coronavirus
vaccine
Criterion met?: NO
Criterion ID: (
For Pfizer use o
nly):EX12A00Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853891
Page 154 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.h Exclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Previous vaccination with any coronavir
us vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:13
Criterion
Descriptio
n:Subjects who receive immu
nosuppressive therapy, such
as cytotoxic agents or syste
mic corticosteroids
Criterion
met?:NO
Criterion
ID: (For P
fizer use o
nly):EX13A01Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853892
Page 155 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.i Exclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Subjects who receive immunosuppressiv
e therapy, such as cytotoxic agents or sy
stemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:15
Criterio
n Descri
ption:Receipt of blood/plasma prod
ucts or immunoglobulin, from
60 days before study intervent
ion administration or planned
receipt throughout the study
Criterio
n met?:NOInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853893
Page 156 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterio
n ID: (F
or Pfize
r use on
ly):EX14A01
2.j Exclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products or im
munoglobulin, from 60 days before stud
y intervention administration or planned
receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853894
Page 157 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
2.k
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numbe
r:16
Criterio
n Descri
ption:Participation in other studies
involving study intervention
within 28 days prior to study
entry and/or during study pa
rticipation
Criterio
n met?:NO
Criterio
n ID: (Fo
r Pfizer
use only)
:EX15A01Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853895
Page 158 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.k Exclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participation in other studies involving s
tudy intervention within 28 days prior t
o study entry and/or during study partici
pationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:17
Criterion
Descriptio
n:Previous participation in ot
her studies involving study
intervention containing lipi
d nanoparticles
Criterion
met?:NOInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853896
Page 159 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterion I
D: (For Pf
izer use on
ly):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Previous participation in other studies in
volving study intervention containing li
pid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:22Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853897
Page 160 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on Des
criptio
n:Investigator site staff or Pfizer
employees directly involved in
the conduct of the study, site st
aff otherwise supervised by th
e investigator, and their respec
tive family members
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX21A01
2.m Exclusion Number:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer employe
es directly involved in the conduct of th
e study, site staff otherwise supervised b
y the investigator, and their respective f
amily membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-18-2020 15:14:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853898
Page 161 of 277
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-18-2020 15:14:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-18-2020 15:14:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-18-2020 15:14:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853899
Page 162 of 277
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 15:15:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-18-2020 15:15:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
74.2Initial Entry
3. Unit:
Date Location User Value Reason
Sep-18-2020 15:15:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-18-2020 15:15:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
162.5Initial Entry
5. Unit:
Date Location User Value Reason
Sep-18-2020 15:15:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-18-2020 15:15:02
(UTC-03:00) City of BuenosACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.1Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853900
Page 163 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aires
7.a
Date Location User Value Reason
Sep-18-2020 15:15:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Location:: FOREHEADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 15:15:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-18-2020 15:15:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-18-2020 15:15:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 15:15:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853901
Page 164 of 277
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020 15:15:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020 15:15:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020 15:15:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-18-2020 15:15:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020 15:15:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-18-2020 15:15:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853902
Page 165 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-18-2020 15:15:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020 15:15:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020 15:15:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853903
Page 166 of 277
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-18-2020 15:16:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-18-2020 15:16:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
93367Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853904
Page 167 of 277
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-19-2020 10:49:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-19-2020 10:49:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-19-2020 10:50:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-19-2020 10:49:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-19-2020 10:49:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-19-2020 10:50:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP7WVJInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-19-2020 10:50:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP7WVJInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853905
Page 168 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.b
Date Location User Value Reason
Sep-19-2020 10:50:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP7WVHInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-19-2020 10:50:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP7WVHInitial Entry
5.c
Date Location User Value Reason
Sep-19-2020 10:50:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP7WVGInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-19-2020 10:50:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP7WVGInitial Entry
5.d
Date Location User Value Reason
Sep-19-2020 10:50:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRXVYYInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-19-2020 10:50:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BRXVYYInitial Entry
5.e
Date Location User Value Reason
Sep-19-2020 10:50:30
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853906
Page 169 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aires Sample ID: BRXVYX
5.e Sample ID
Date Location User Value Reason
Sep-19-2020 10:50:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BRXVYXInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853907
Page 170 of 277
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-19-2020 11:35:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-19-2020 11:35:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-19-2020 11:35:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-19-2020 11:35:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-19-2020 11:35:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-19-2020 11:35:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP7WZ9Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-19-2020 11:35:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP7WZ9Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0853908
Page 171 of 277
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 15:16:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 15:16:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 15:16:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 15:16:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/18/2020 11:44Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 15:16:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020 15:16:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0853909
Page 172 of 277
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7. Route:
Date Location User Value Reason
Sep-18-2020 15:16:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020 15:16:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-18-2020 15:16:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0853910
Page 173 of 277
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-18-2020 15:17:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY N
OT COLLECTED FOR THIS SUBJEC
TInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853911
Page 174 of 277
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-10-2020 10:00:00
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853912
Page 175 of 277
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Oct-10-2020 10:00:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
2.a
Date Location User Value Reason
Oct-10-2020 10:00:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Location:: FOREHEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-10-2020 10:00:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-10-2020 10:00:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-10-2020 10:00:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-10-2020 10:00:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853913
Page 176 of 277
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-10-2020 10:00:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-10-2020 10:00:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-10-2020 10:00:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-10-2020 10:00:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-10-2020 10:00:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-10-2020 10:00:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853914
Page 177 of 277
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
6.a Sponsor ID:
Date Location User Value Reason
Oct-10-2020 10:00:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-10-2020 10:00:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-10-2020 10:00:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853915
Page 178 of 277
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-10-2020 10:02:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-10-2020 10:02:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-10-2020 10:02:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-10-2020 10:02:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-10-2020 10:02:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/9/2020Initial Entry
5.a
Date Location User Value Reason
Oct-10-2020 10:02:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPWZFJInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-10-2020 10:02:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BPWZFJInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853916
Page 179 of 277
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-10-2020 10:00:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-10-2020 10:00:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-10-2020 10:00:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-10-2020 10:00:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/9/2020 13:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-10-2020 10:00:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-10-2020 10:00:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853917
Page 180 of 277
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-10-2020 10:00:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-10-2020 10:00:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-10-2020 10:00:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853918
Page 181 of 277
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-11-2020 14:46:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Nov/11/2020Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0853919
Page 182 of 277
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020 17:58:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020 17:58:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-11-2020 17:58:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-11-2020 17:58:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-11-2020 17:58:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/11/2020Initial Entry
5.a
Date Location User Value Reason
Nov-11-2020 17:58:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR697JInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-11-2020 17:58:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BR697JInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853920
Page 183 of 277
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.b
Date Location User Value Reason
Nov-11-2020 17:58:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2XJYInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-11-2020 17:58:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BS2XJYInitial Entry
5.c
Date Location User Value Reason
Nov-11-2020 17:58:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2XJXInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-11-2020 17:58:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BS2XJXInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853921
Page 184 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-17-2020 11:05:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-17-2020 10:12:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please review
and update as
appropriate.
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Dec-17-2020 07:16:26
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the
Signs and Symptoms
form is missing. Please
review and update as
appropriate.
Dec-17-2020 07:16:26
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please review
and update as
appropriate.
Dec-17-2020 07:16:26
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Dec/16/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-17-2020 07:16:26
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853922
Page 185 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Dec/16/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Dec/10/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-13-2021 10:55:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolved:
Jan/1/2021New Information
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853923
Page 186 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASE
D COUGH
Symptom Pr
esent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREASED S
HORTNESS OF BREATH
Symptom
Present:NOInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853924
Page 187 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4.c Symptoms:
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTNESS
OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAIN
Symptom P
resent:YESInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853925
Page 188 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4.e Symptoms:
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCLE PAI
NInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: NEW LOSS OF TASTE
OR SMELL
Symptom Pr
esent:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED
SORE THROAT
Symptom P
resent:YESInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853926
Page 189 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4.g Symptoms:
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE THRO
ATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHEA
Symptom Present: YESInitial Entry
4.h Symptoms:
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853927
Page 190 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4.i Symptoms:
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Dec-17-2020 07:19:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Dec-17-2020 07:21:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptoms -
Other:Increased body tempera
ture 37.8 CInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Dec-17-2020 07:21:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Increased body temperature 37.8 CInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853928
Page 191 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Dec-17-2020 12:00:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853929
Page 192 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Dec-17-2020 12:00:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Dec/11/2020Initial Entry
Dec-17-2020 11:59:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry: Initial Entry
Dec-17-2020 07:21:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Specimen Type:
Date Location User Value Reason
Dec-17-2020 12:00:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
Dec-17-2020 11:59:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry: Initial Entry
Dec-17-2020 07:21:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Dec-17-2020 12:00:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
Dec-17-2020 11:59:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry: Initial Entry
Dec-17-2020 07:21:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853930
Page 193 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Dec-17-2020 12:00:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDROME
CORONAVIRUS 2Initial Entry
Dec-17-2020 11:59:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry: Initial Entry
Dec-17-2020 07:21:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Device Type:
Date Location User Value Reason
Dec-17-2020 12:00:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
Dec-17-2020 11:59:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry: Initial Entry
Dec-17-2020 07:21:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Trade Name:
Date Location User Value Reason
Dec-17-2020 12:00:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
Dec-17-2020 11:59:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry: Initial Entry
Dec-17-2020 07:21:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Test Result:
Date Location User Value Reason
Dec-17-2020 12:00:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
Dec-17-2020 11:59:58
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853931
Page 194 of 277
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
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: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aires
Dec-17-2020 07:21:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Dec-17-2020 11:59:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry: Initial Entry
Dec-17-2020 07:21:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Dec-17-2020 12:00:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NALT UnknownInitial Entry
Dec-17-2020 11:59:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry: Initial Entry
Dec-17-2020 07:21:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853932
Page 195 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020 11:06:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020 11:06:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020 11:06:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Dec-17-2020 11:06:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
The collection was made in site.Initial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0853933
Page 196 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020 11:05:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020 11:05:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020 11:05:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-17-2020 11:05:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-17-2020 11:05:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/16/2020Initial Entry
5.a
Date Location User Value Reason
Dec-17-2020 11:05:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRGTJRInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-17-2020 11:05:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BRGTJRInitial Entry
090177e196ae4075\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0853934
Page 197 of 277
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Medicos Ltda
Subject No: 12261836 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Dec-17-2020 07:22:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIALI
ST
Occurrence of Visits or C
ontacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Dec-17-2020 07:22:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contact
…[truncated]