Document text
Page 1 of 161
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 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
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849438
Page 2 of 161
***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: 12261300 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
Aug/20/2020
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849439
Page 3 of 161
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12261300]
2.Birth Date: 1976
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849440
Page 4 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/20/2020
2.Erroneous Visit
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849441
Page 5 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 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: 12261300 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
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849442
Page 6 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterion ID: (For Pfizer use only) EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
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
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849443
Page 7 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
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
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849444
Page 8 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849445
Page 9 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[obesity]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[renal lithiasis]
Start Date: Apr/UNK/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vasectomy]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849446
Page 10 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
2.Weight: [92.3]
3.Unit: kg
4.Height: [175.0]
5.Unit: cm
6.Body Mass Index: [30.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849447
Page 11 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/20/2020
2.Randomization Number: [56368]
3.Randomization Group: [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849448
Page 12 of 161
***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: 12261300 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:
Aug/20/2020
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 [BP5TV5]
5.bSample ID [BP5TV4]
5.cSample ID [BP5TV3]
5.dSample ID [BLCJ5S]
5.eSample ID [BLCJ5R]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849449
Page 13 of 161
***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: 12261300 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:
Aug/20/2020
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 [BP5TYG]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849450
Page 14 of 161
***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: 12261300 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: Aug/20/2020 09:39
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
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849451
Page 15 of 161
***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: 12261300 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
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849452
Page 16 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/11/2020
2.Erroneous Visit
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849453
Page 17 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/11/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849454
Page 18 of 161
***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: 12261300 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/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 [BPWTRZ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849455
Page 19 of 161
***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: 12261300 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/11/2020 08:44
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
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849456
Page 20 of 161
***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: 12261300 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
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849457
Page 21 of 161
***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: 12261300 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:
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 [BRVBFW]
5.bSample ID [BRVBFV]
5.cSample ID [BPWZDJ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849458
Page 22 of 161
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849459
Page 23 of 161
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_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: 12261300 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:
Mar/5/2021
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 [BRGYZT]
5.bSample ID [BRXW58]
5.cSample ID [BRXW63]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849460
Page 24 of 161
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849461
Page 25 of 161
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 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 [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849462
Page 26 of 161
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849463
Page 27 of 161
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 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 [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849464
Page 28 of 161
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849465
Page 29 of 161
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849466
Page 30 of 161
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 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 [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849467
Page 31 of 161
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 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 [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849468
Page 32 of 161
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849469
Page 33 of 161
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849470
Page 34 of 161
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849471
Page 35 of 161
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 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 [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849472
Page 36 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849473
Page 37 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849474
Page 38 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/9/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849475
Page 39 of 161
***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: 12261300 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: [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849476
Page 40 of 161
***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: 12261300 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:
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849477
Page 41 of 161
***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: 12261300 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 [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849478
Page 42 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849479
Page 43 of 161
***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: 12261300 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:
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849480
Page 44 of 161
***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: 12261300 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?
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849481
Page 45 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849482
Page 46 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849483
Page 47 of 161
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849484
Page 48 of 161
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849485
Page 49 of 161
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 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 [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849486
Page 50 of 161
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 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 [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849487
Page 51 of 161
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/30/2021
2.Erroneous Visit
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849488
Page 52 of 161
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849489
Page 53 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Identifi
erAdverse Eve
ntStart DateIs the Adverse Event Still Ong
oingForm Instance
1.ADVERSE EVE
NT 1 Renal colic Aug/29/2020 05:00 NO
End Date Time:
Aug/30/2020 12:00
Repeating
Pages
2.ADVERSE EVE
NT 2 Conjunctiviti
s Sep/1/2020 UNK:U
NK NO
End Date Time:
Sep/7/2020 UNK:UNK
Repeating
Pages
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849490
Page 54 of 161
***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: 12261300 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)[Renal colic]
4.Start Date Time: Aug/29/2020 05:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/30/2020 12:00
6.Toxicity Grade: 4
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:
[Renal lithiasis]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849491
Page 55 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?: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[2020339055]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849492
Page 56 of 161
***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: 12261300 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)[Conjunctivitis]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/7/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[possible cause: bacterial]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849493
Page 57 of 161
***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: 12261300 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[ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849494
Page 58 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
1. Repeating
Pages
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849495
Page 59 of 161
***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: 12261300 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[ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849496
Page 60 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-De
fined Identi
fierCategory f
or Medicat
ionConcomitant Me
dications Pre-spe
cifiedName of MedicationStart
DateForm Insta
nce
1. DELETED 1 VACCINA
TIONS NO BUSCOPAN COMPOUND (SCOPOL
AMINE BUTYLBROMIDE,DIPYRO
NE) 1 TABLET Aug/2
9/202
0 Repeating
Pages
2. DELETED 2 VACCINA
TIONS NO Tramadol 100mg IV PRN Aug/2
9/202
0 Repeating
Pages
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849497
Page 61 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[BUSCOPAN COMPOUND (SCOPOLAMINE BUTYLBROMIDE,DIPYRONE) 1
TABLET ]
5.Date: Aug/29/2020
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849498
Page 62 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Tramadol 100mg IV PRN ]
5.Date: Aug/29/2020
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849499
Page 63 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849500
Page 64 of 161
***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: 12261300 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?
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849501
Page 65 of 161
***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: 12261300 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
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849502
Page 66 of 161
***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: 12261300 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?
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849503
Page 67 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849504
Page 68 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849505
Page 69 of 161
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849506
Page 70 of 161
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Booster Dose Trigger Form
1.Select appropriate response - Will the
participant return for
consent/eligibility assessment for the
booster dose visit?
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849507
Page 71 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/1/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849508
Page 72 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849509
Page 73 of 161
***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: 12261300 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: [ ]
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849510
Page 74 of 161
***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: 12261300 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 Oct/9/2020
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849511
Page 75 of 161
***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: 12261300 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
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849512
Page 76 of 161
***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: 12261300 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-05-2021 15:40:02 (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.
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849513
Page 77 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormAug-24-2020 10:08:05 (UTC-03:00) City of
Buenos Aires
FormAug-20-2020 16:56:18 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849514
Page 78 of 161
***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: 12261300 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-05-2021 15:40:02 (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-05-2021 13:16:06 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Mar-05-2021 11:03:55 (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-05-2021 09:51:25 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Feb-11-2021 10:36:27 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849515
Page 79 of 161
***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: 12261300 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 Feb-03-2021 10:59:33 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Oct-21-2020 17:14:20 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849516
Page 80 of 161
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 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
Aug-20-2020 16:53:50
(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
Aug-20-2020 16:53:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849517
Page 81 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-20-2020 16:53:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/20/2020Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849518
Page 82 of 161
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-20-2020 16:53:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12261300Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-20-2020 16:53:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1976Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-20-2020 16:54:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-20-2020 16:54:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-20-2020 16:54:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849519
Page 83 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-20-2020 16:54:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849520
Page 84 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:1
Criter
ion De
scripti
on:Male or female participants
between the ages of 18 and
55 years, inclusive, 65 and
85 years, inclusive, or 18 an
d 85 years, inclusive, at ran
domization (dependent upo
n study stage)
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Male or female participants between
the ages of 18 and 55 years, inclusiv
e, 65 and 85 years, inclusive, or 18 a
nd 85 years, inclusive, at randomizat
ion (dependent upon study stage)Initial Entry
1.a Criterion met?
090177e196ae4071\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-2021-5683-0849521
Page 85 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willin
g and able to comply with a
ll scheduled visits, vaccinat
ion plan, laboratory tests, li
festyle considerations, and
other study procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN02A00Initial Entry
090177e196ae4071\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-2021-5683-0849522
Page 86 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Inclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participants who are willing and able
to comply with all scheduled visits, v
accination plan, laboratory tests, life
style considerations, and other study
proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who ar
e determined by medical hi
story, physical examination
, and clinical judgment of t
he investigator to be eligibl
e for inclusion in the studyInitial Entry
090177e196ae4071\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-2021-5683-0849523
Page 87 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants who are determi
ned by medical history, physical exa
mination, and clinical judgment of th
e investigator to be eligible for inclu
sion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
090177e196ae4071\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)
FDA-CBER-2021-5683-0849524
Page 88 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4
Criteri
on Des
criptio
n:Capable of giving personal
signed informed consent, w
hich includes compliance
with the requirements and r
estrictions listed in the ICD
and in this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only):IN04A00Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849525
Page 89 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.d Inclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Capable of giving personal signed in
formed consent, which includes com
pliance with the requirements and re
strictions listed in the ICD and in thi
s protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae4071\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-2021-5683-0849526
Page 90 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on Des
criptio
n:Other medical or psychiatri
c condition incl. recent (wit
hin past year) or active suic
idal ideation/behavior/lab a
bnormality that may increas
e the risk of study participat
ion
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Other medical or psychiatric conditi
on incl. recent (within past year) or a
ctive suicidal ideation/behavior/lab a
bnormality that may increase the risk
of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae4071\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-2021-5683-0849527
Page 91 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with hu
man immunodeficiency v
irus (HIV), hepatitis C vir
us (HCV), or hepatitis B
virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX02A00Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849528
Page 92 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.b Exclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with human immun
odeficiency virus (HIV), hepatitis C
virus (HCV), or hepatitis B virus (H
BV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse r
eaction associated with a v
accine and/or severe allergi
c reaction (eg, anaphylaxis)
to any component of the st
udy intervention(s)Initial Entry
090177e196ae4071\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-2021-5683-0849529
Page 93 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
History of severe adverse reaction as
sociated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to
any component of the study intervent
ion(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
090177e196ae4071\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)
FDA-CBER-2021-5683-0849530
Page 94 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:4
Criterion Des
cription:Receipt of medicatio
ns intended to preve
nt COVID-19
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX04A00Initial Entry
2.d Exclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of medications intended to p
revent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
090177e196ae4071\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-2021-5683-0849531
Page 95 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:8
Criteri
on Desc
ription:Immunocompromised indi
viduals with known or sus
pected immunodeficiency,
as determined by history a
nd/or laboratory/physical e
xamination
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX08A00Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849532
Page 96 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.e Exclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Immunocompromised individuals wi
th known or suspected immunodefici
ency, as determined by history and/o
r laboratory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:10
Criteri
on Des
criptio
n:Bleeding diathesis or condi
tion associated with prolon
ged bleeding that would, in
the opinion of the investiga
tor, contraindicate intramus
cular injectionInitial Entry
090177e196ae4071\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-2021-5683-0849533
Page 97 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition assoc
iated with prolonged bleeding that w
ould, in the opinion of the investigat
or, contraindicate intramuscular injec
tionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
090177e196ae4071\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)
FDA-CBER-2021-5683-0849534
Page 98 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Num
ber:11
Criterion Descr
iption:Women who are p
regnant or breastfe
eding
Criterion met?: NO
Criterion ID: (
For Pfizer use
only):EX11A00Initial Entry
2.g Exclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Women who are pregnant or breastfe
edingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4071\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) (6)
(b) (4)
FDA-CBER-2021-5683-0849535
Page 99 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinatio
n with any coronavi
rus vaccine
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous vaccination with any coron
avirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4071\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) (6)
(b) (4)
FDA-CBER-2021-5683-0849536
Page 100 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires Exclusio
n Numbe
r:13
Criterion
Descripti
on:Subjects who receive im
munosuppressive therapy
, such as cytotoxic agent
s or systemic corticoster
oids
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive immunosuppre
ssive therapy, such as cytotoxic agen
ts or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
090177e196ae4071\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-2021-5683-0849537
Page 101 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.j
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma pr
oducts or immunoglobulin,
from 60 days before study
intervention administration
or planned receipt through
out the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX14A01Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849538
Page 102 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.j Exclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products or
immunoglobulin, from 60 days befor
e study intervention administration o
r planned receipt throughout the stud
yInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae4071\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)
FDA-CBER-2021-5683-0849539
Page 103 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
2.k
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other stud
ies involving study interv
ention within 28 days prio
r to study entry and/or dur
ing study participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849540
Page 104 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.k Exclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other studies involvi
ng study intervention within 28 days
prior to study entry and/or during st
udy participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:17
Criterion
Descripti
on:Previous participation in
other studies involving s
tudy intervention contai
ning lipid nanoparticles
Criterion
met?:NOInitial Entry
090177e196ae4071\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-2021-5683-0849541
Page 105 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criterion
ID: (For
Pfizer use
only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participation in other studi
es involving study intervention cont
aining lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:22Initial Entry
090177e196ae4071\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-2021-5683-0849542
Page 106 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Criteri
on Des
criptio
n:Investigator site staff or Pfi
zer employees directly invo
lved in the conduct of the st
udy, site staff otherwise sup
ervised by the investigator,
and their respective family
members
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX21A01
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849543
Page 107 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.m Exclusion Number:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer empl
oyees directly involved in the condu
ct of the study, site staff otherwise s
upervised by the investigator, and th
eir respective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 16:55:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae4071\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)
FDA-CBER-2021-5683-0849544
Page 108 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 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
Aug-20-2020 16:55:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-20-2020 16:55:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-20-2020 16:55:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849545
Page 109 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Aug-24-2020 10:08:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:obesity
Start Date: UNK/UNK/20
00
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-24-2020 10:08:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 10:08:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
obesityInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-24-2020 10:08:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-24-2020 10:08:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae4071\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-2021-5683-0849546
Page 110 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-02-2020 12:29:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:renal lithiasis
Start Date: Apr/UNK/20
20
Ongoing: YESInitial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849547
Page 111 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b Line/MH Number:
Date Location User Value Reason
Sep-02-2020 12:29:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 16:40:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Sep-23-2020 15:16:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The subject has the
medical history of
Renal lithiasis since
Apr/2020. The
endoscopic
ureterolithotripsy
happened on 30/Aug
/2020.
Sep-21-2020 21:52:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:Opened Procedure was
performed on
Apr2020 (before
study). Surgeries
could be recorded if
clinically relevant to
current AE as part of
the Med Hx. Per
section 8.7.2. of CRF
competition
guidelines. Thank
you.
Sep-21-2020 17:27:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered There is no field
available for
procedures performed
during the study.
Information was
recivied by SAE
form.
Sep-18-2020 09:38:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Subject has a history
of endoscopic
ureterolithotripsy
performed on
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0849548
Page 112 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Apr2020 recorded on
SDB. This
information is not
reflected on CRF.
Please revise/update
accordingly. Thank
you.
Sep-02-2020 12:29:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
renal lithiasisInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-02-2020 12:29:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Apr/UNK/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-02-2020 12:29:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-21-2020 17:11:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:3
Medical History
Term:Vasectomy
Start Date: UNK/UNK/201
5
Ongoing: NO
End Date:
UNK/UNK/
2015Initial Entry
Sep-21-2020 17:10:54 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae4071\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)
FDA-CBER-2021-5683-0849549
Page 113 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-03:00) City of
Buenos Aires(autocalc) Line/MH Number
:3
Medical History T
erm:Vasectomy
Start Date: UNK/UNK/2
015
Ongoing:
1.c Line/MH Number:
Date Location User Value Reason
Sep-21-2020 17:10:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020 17:10:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
VasectomyInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-21-2020 17:10:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-21-2020 17:11:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
090177e196ae4071\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-2021-5683-0849550
Page 114 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Aug-20-2020 16:57:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-20-2020 16:57:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
92.3Initial Entry
3. Unit:
Date Location User Value Reason
Aug-20-2020 16:57:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-20-2020 16:57:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
175.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-20-2020 16:57:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-20-2020 16:57:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.1Initial Entry
090177e196ae4071\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-2021-5683-0849551
Page 115 of 161
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7.a
Date Location User Value Reason
Aug-20-2020 16:57:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.4
Temperature Unit: C
Temperature Locatio
n::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-20-2020 16:57:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-20-2020 16:57:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-20-2020 16:57:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-20-2020 16:57:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae4071\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-2021-5683-0849552
Page 116 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-20-2020 16:59:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-20-2020 16:59:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
56368Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849553
Page 117 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 07:13:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 07:13:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 07:13:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-21-2020 07:13:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-21-2020 07:13:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020 07:13:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP5TV5Initial Entry
5.a Sample ID
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849554
Page 118 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-21-2020 07:13:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP5TV5Initial Entry
5.b
Date Location User Value Reason
Aug-21-2020 07:13:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP5TV4Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-21-2020 07:13:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP5TV4Initial Entry
5.c
Date Location User Value Reason
Aug-21-2020 07:14:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP5TV3Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-21-2020 07:14:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP5TV3Initial Entry
5.d
Date Location User Value Reason
Aug-21-2020 08:33:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLCJ5SInitial Entry
090177e196ae4071\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) (6)
(b) (4)
FDA-CBER-2021-5683-0849555
Page 119 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.d Sample ID
Date Location User Value Reason
Aug-21-2020 08:33:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLCJ5SInitial Entry
5.e
Date Location User Value Reason
Aug-21-2020 08:33:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLCJ5RInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-21-2020 08:33:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLCJ5RInitial Entry
090177e196ae4071\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-2021-5683-0849556
Page 120 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 07:14:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 07:14:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 07:14:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-21-2020 07:14:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-21-2020 07:14:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020 07:14:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP5TYGInitial Entry
5.a Sample ID
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849557
Page 121 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Aug-21-2020 07:14:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP5TYGInitial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849558
Page 122 of 161
***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: 12261300 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
Aug-20-2020 17:00:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020 17:00:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-20-2020 17:00:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-20-2020 17:00:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/20/2020 09:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020 17:00:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-20-2020 17:00:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae4071\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-2021-5683-0849559
Page 123 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7. Route:
Date Location User Value Reason
Aug-20-2020 17:00:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-20-2020 17:00:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-20-2020 17:00:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849560
Page 124 of 161
***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: 12261300 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
Aug-20-2020 17:00:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849561
Page 125 of 161
***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: 12261300 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-11-2020 14:29:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849562
Page 126 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Sep-11-2020 14:29:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
2.a
Date Location User Value Reason
Sep-11-2020 14:29:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Locatio
n::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-11-2020 14:29:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-11-2020 14:29:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-11-2020 14:29:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae4071\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-2021-5683-0849563
Page 127 of 161
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.a Temperature Location:
Date Location User Value Reason
Sep-11-2020 14:29:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849564
Page 128 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020 16:31:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020 16:31:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020 16:31:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-11-2020 16:31:11
(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-11-2020 16:31:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020 16:31:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPWTRZInitial Entry
5.a Sample ID
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849565
Page 129 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Sep-11-2020 16:31:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPWTRZInitial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849566
Page 130 of 161
***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: 12261300 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-11-2020 14:31:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020 14:31:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-11-2020 14:31:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-11-2020 14:31:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/11/2020 08:44Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020 14:31:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-11-2020 14:31:02 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4071\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-2021-5683-0849567
Page 131 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-03:00) City of
Buenos AiresLEFT
7. Route:
Date Location User Value Reason
Sep-11-2020 14:31:02
(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-11-2020 14:31:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-11-2020 14:31:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849568
Page 132 of 161
***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: 12261300 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-09-2020 15:45:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/9/2020Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849569
Page 133 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-09-2020 17:21:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-09-2020 17:21:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-09-2020 17:21:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-09-2020 17:21:11
(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-09-2020 17:21:11
(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-09-2020 17:21:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRVBFWInitial Entry
5.a Sample ID
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849570
Page 134 of 161
***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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Oct-09-2020 17:21:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRVBFWInitial Entry
5.b
Date Location User Value Reason
Oct-09-2020 17:21:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRVBFVInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-09-2020 17:21:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRVBFVInitial Entry
5.c
Date Location User Value Reason
Oct-09-2020 17:21:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPWZDJInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-09-2020 17:21:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPWZDJInitial Entry
090177e196ae4071\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-2021-5683-0849571
Page 135 of 161
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-05-2021 09:51:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/5/2021Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849572
Page 136 of 161
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-05-2021 13:16:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-05-2021 13:16:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-05-2021 13:16:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-05-2021 13:16:06
(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.
Mar-05-2021 13:16:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/5/2021Initial Entry
5.a
Date Location User Value Reason
Mar-05-2021 13:16:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRGYZTInitial Entry
5.a Sample ID
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849573
Page 137 of 161
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_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: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Mar-05-2021 13:16:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRGYZTInitial Entry
5.b
Date Location User Value Reason
Mar-05-2021 13:16:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRXW58Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-05-2021 13:16:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRXW58Initial Entry
5.c
Date Location User Value Reason
Mar-05-2021 13:16:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRXW63Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-05-2021 13:16:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRXW63Initial Entry
090177e196ae4071\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-2021-5683-0849574
Page 138 of 161
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 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
Oct-09-2020 15:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020 15:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020 15:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0849575
Page 139 of 161
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021 10:59:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/30/2021Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849576
Page 140 of 161
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-03-2021 10:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-03-2021 10:59:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Feb-03-2021 10:59:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed to
have received only placebo at V
accination 1/2Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849577
Page 141 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Sep-01-2020 15:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849578
Page 142 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Date Location User Value Reason
Sep-01-2020 15:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849579
Page 143 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Sep-01-2020 15:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-01-2020 15:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-22-2020 00:31:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Thank you.
Oct-21-2020 15:46:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Changed data per
query
Oct-21-2020 12:08:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened COVID testing has
not been reported in
the SAE submitted
to safety. Please
submit a follow-up
SAE form to provide
whether COVID
testing was
performed (yes/no)
and if yes, the
results. Thank you.
Sep-01-2020 15:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Renal colicInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0849580
Page 144 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-01-2020 15:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/29/2020 05:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-01-2020 15:12:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/30/2020 12:00New Information
Sep-01-2020 15:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/30/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-01-2020 15:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-02-2020 08:53:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-01-2020 15:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Renal colic:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
090177e196ae4071\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)
FDA-CBER-2021-5683-0849581
Page 145 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-01-2020 15:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated wit
h congenital anomaly or birth defe
ct?
NO
Did this serious event result in deat
h?
NO
Did this serious event require or pr
olong hospitalization?
YES
Did this serious event result in pers
istent or significant disability/incap
acity?
NO
Is this serious event life threatenin
g?
NO
Other medically important serious
event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-01-2020 15:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-01-2020 15:05:19 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4071\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-2021-5683-0849582
Page 146 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
(UTC-03:00) City of
Buenos AiresNOT RELATED
If Not Related to study treatment(s)
, this event is due to:
OTHER
If Other, specify:
Renal lithiasis
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-01-2020 15:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-01-2020 15:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-01-2020 15:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-01-2020 15:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-01-2020 15:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4071\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) (6)
(b) (4)
FDA-CBER-2021-5683-0849583
Page 147 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-02-2020 08:53:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2020339055Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0849584
Page 148 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Category:
Date Location User Value Reason
Sep-01-2020 15:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-01-2020 15:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-01-2020 15:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ConjunctivitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-01-2020 15:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/1/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-14-2020 13:44:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-13-2020 18:34:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered the ending date is the
new information.
Oct-13-2020 18:27:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened Could you clarify
which is the new
information, please
090177e196ae4071\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-2021-5683-0849585
Page 149 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-09-2020 15:34:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-09-2020 15:34:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/7/2020 UNK:UNKNew Information
Oct-08-2020 16:33:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLINQUERY: please
confirm temporary
delay was not needed
48 hs before
vaccination since the
event was still
ongoing
Sep-01-2020 15:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-01-2020 15:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-01-2020 15:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae4071\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-2021-5683-0849586
Page 150 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Sep-01-2020 15:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-01-2020 15:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s)
, this event is due to:
OTHER
If Other, specify:
possible cause: bacterialInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-01-2020 15:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-01-2020 15:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-01-2020 15:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-09-2020 15:35:05
(UTC-03:00) City ofACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae4071\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-2021-5683-0849587
Page 151 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires
Oct-09-2020 15:35:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Oct-09-2020 15:34:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Conjunctivitis:
Response to "What was
the outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Sep-01-2020 15:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-01-2020 15:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4071\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-2021-5683-0849588
Page 152 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Sep-03-2020 11:09:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Deleted Transcription
Error
Sep-01-2020 15:07:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849589
Page 153 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Sep-03-2020 11:09:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Deleted Transcription
Error
Sep-01-2020 15:08:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0849590
Page 154 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Sep-01-2020 15:07:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Sep-03-2020 10:11:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed query placed
somewhere else
Sep-02-2020 17:41:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Please report here
only concomitant
vaccination.
Sep-01-2020 15:07:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Sep-01-2020 15:07:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User ValueReason
Sep-08-2020
16:28:16
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
2: Clo
sedcorrect answer
090177e196ae4071\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-2021-5683-0849591
Page 155 of 161
***Confidential***
Sep-03-2020
11:09:14
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query
2: Ans
weredTranscription Error
Sep-03-2020
10:16:47
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
2: Op
enedPlease report here only vaccines
(vaccines that are not study
vaccines). Medication as
Buscopam should not be reported
in this page. This is exclusively
for NON Study Vaccines
Sep-02-2020
14:59:57
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has been closed.
Sep-02-2020
12:20:49
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredNew Information
Sep-02-2020
12:20:49
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
BUSC
OPAN
COM
POU
ND (S
COP
OLA
MINE
BUT
YLB
ROMI
DE,DI
PYR
ONE)
1 TA
BLETNew Information
Sep-01-2020
21:14:09
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedClarify BUSCOPAM
COMPOUND (SCOPOLAMINE
BUTYLBROMIDE,DIPYRONE)
1 TABLET as follows...Should
the spelling be BUSCOPAN
COMPOUND (SCOPOLAMINE
BUTYLBROMIDE,DIPYRONE)
1 TABLET? If so, update the
verbatim term as such. Otherwise
clarify and update the term as
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0849592
Page 156 of 161
***Confidential***
appropriate or provide
reference/label. Thank you.
Sep-01-2020
15:09:13
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
Busco
pam c
ompo
und (s
copol
amine
butylb
romid
e,dipy
rone)
1 tabl
etTranscription Error
Sep-01-2020
15:07:59
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
Busco
pam c
ompo
und (s
copol
amine
butylb
romid
e,dipy
rone)Initial Entry
5. Date:
Date Location User Value Reason
Sep-01-2020 15:07:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/29/2020Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0849593
Page 157 of 161
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Sep-01-2020 15:08:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
2. Category:
Date Location User Value Reason
Sep-03-2020 10:12:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed query placed
elsewhere
Sep-02-2020 17:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Please report here
only concomitant
vaccination
Sep-01-2020 15:08:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Sep-01-2020 15:08:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Sep-08-2020 16:28:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed correct answer
Sep-03-2020 11:09:02 ACV0PFEINFP6000 auto query Query 1: Answered Transcription Error
090177e196ae4071\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-2021-5683-0849594
Page 158 of 161
***Confidential***
(UTC-03:00) City of
Buenos Aires(autoquery)
Sep-03-2020 10:15:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Please report here
only vaccines
(vaccines that are not
study vaccines).
Medication as
Tramadol should not
be reported in this
page. This is
exclusively for NON
Study Vaccines
Sep-01-2020 15:08:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Tramadol 100mg IV PRNInitial Entry
5. Date:
Date Location User Value Reason
Sep-01-2020 15:08:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/29/2020Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0849595
Page 159 of 161
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-03-2021 10:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/1/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-03-2021 10:59:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR ADD
ITIONAL VACCINATIONInitial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0849596
Page 160 of 161
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-09-2020 15:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-20-2020 16:59:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-20-2020 16:55:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-09-2020 15:46:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Initial Entry
Aug-20-2020 16:59:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
Aug-20-2020 16:55:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0849597
Page 161 of 161
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020 15:46:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae4071\Final\Final On: 01-Apr-2021 05:40 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0849598