125742 S1 M5 CRF c4591001 1226 12262000

Document text

Page 1 of 329
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854214
Page 2 of 329
***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: 12262000 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
Oct/1/2020
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854215
Page 3 of 329
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12262000]
2.Birth Date: /1968
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854216
Page 4 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854217
Page 5 of 329
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854218
Page 6 of 329
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854219
Page 7 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[obesity]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[constipation]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[withdrawal of nasal basal cell cancer]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hepatic steatosis]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854220
Page 8 of 329
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854221
Page 9 of 329
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Oct/1/2020
2.Weight: [88.5]
3.Unit: kg
4.Height: [165.3]
5.Unit: cm
6.Body Mass Index: [32.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: FOREHEAD
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854222
Page 10 of 329
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/1/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854223
Page 11 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/1/2020
2.Randomization Number: [102823]
3.Randomization Group: [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854224
Page 12 of 329
***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: 12262000 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/1/2020
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 [BP7XSG]
5.bSample ID [BLC0MF]
5.cSample ID [BLC0MG]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854225
Page 13 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
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 [BP7XST]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854226
Page 14 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/1/2020 13:30
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
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854227
Page 15 of 329
***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: 12262000 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
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854228
Page 16 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854229
Page 17 of 329
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Oct/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854230
Page 18 of 329
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/22/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854231
Page 19 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
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 [BR6NM1]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854232
Page 20 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/22/2020 10:48
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854233
Page 21 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/23/2020
2.Erroneous Visit
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854234
Page 22 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/23/2020
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 [BS2XX7]
5.bSample ID [BS2XX6]
5.cSample ID [BR60DY]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854235
Page 23 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/23/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854236
Page 24 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/23/2020
2.Date of First Symptom Started: Nov/21/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/26/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854237
Page 25 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854238
Page 26 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descrip
tionDevice Type Form Instance
 1.Not Applicable  Not Applicab
le Not Applicable  Not Applicable  Not Applicab
le Repeating
Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854239
Page 27 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854240
Page 28 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[collected swab on site, recorded at swab pfe]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854241
Page 29 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/23/2020
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 [BR60F6]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854242
Page 30 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Not Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854243
Page 31 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Jan/3/2021  NO
Discharge Date:
Jan/14/2021
 Repeating Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854244
Page 32 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Jan/3/2021
4.Ongoing? NO
Discharge Date:
Jan/14/2021
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854245
Page 33 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854246
Page 34 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854247
Page 35 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854248
Page 36 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854249
Page 37 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854250
Page 38 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854251
Page 39 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854252
Page 40 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854253
Page 41 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854254
Page 42 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Nov/23/2020 Record Identifier: Systolic: Diastolic:
1  127  91 Repeating Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854255
Page 43 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [127]
Diastolic: [91]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [71]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854256
Page 44 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Nov/23/2020 Record Identifier: Oxygen Saturation
1  96.0 Repeating Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854257
Page 45 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/23/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [96.0]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854258
Page 46 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854259
Page 47 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854260
Page 48 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854261
Page 49 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854262
Page 50 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854263
Page 51 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854264
Page 52 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854265
Page 53 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/22/2020
2.Date of First Symptom Started: Dec/20/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/14/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854266
Page 54 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Symptoms - Other
5.aSymptoms - Other Text: [Runny nose]
5.bSymptoms - Other Text: [Nasal congestion]
5.cSymptoms - Other Text: [Body increased temperature (37.7 C)]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854267
Page 55 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of C
ollectionSpecimen Typ
eSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/3/2021
 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854268
Page 56 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/3/2021 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: POSITIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [NALT UNKNOWN] Comments
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854269
Page 57 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Sample was collected on site, recorded at swab pfe]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854270
Page 58 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/22/2020
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 [BP9905]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854271
Page 59 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
YES
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854272
Page 60 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: HOSPITALIZATION DETAILS
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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  ICU  Jan/3/2021  YES  Repeating Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854273
Page 61 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: ICU
3.Admission Date: Jan/3/2021
4.Ongoing? YES
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854274
Page 62 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Treatment Id
entifierCon Non-Drug Treatments
Pre-specifiedTreatment TreatmentStart D
ateForm Instanc
e
 1.1  YES  MECHANICAL VEN
TILATION MECHANICAL VEN
TILATION Jan/3/2
021 Repeating
Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854275
Page 63 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: MECHANICAL VENTILATION
4.Treatment: [MECHANICAL VENTILATION]
5.Start Date: Jan/3/2021
6.Ongoing? YES
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854276
Page 64 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19]
Date of Diagnosis:
Jan/7/2021
3.Toxicity Grade: 1
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854277
Page 65 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854278
Page 66 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854279
Page 67 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854280
Page 68 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854281
Page 69 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854282
Page 70 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854283
Page 71 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Dec/22/2020 Record Identifier: Systolic: Diastolic:
1  138  77 Repeating Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854284
Page 72 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [138]
Diastolic: [77]
Respiratory Rate in
respirations/minute:[12]
Heart Rate in beats/minute: [76]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854285
Page 73 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Dec/22/2020 Record Identifier: Oxygen Saturation
1  99.0 Repeating Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854286
Page 74 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/22/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854287
Page 75 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854288
Page 76 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854289
Page 77 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854290
Page 78 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854291
Page 79 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854292
Page 80 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854293
Page 81 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/22/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854294
Page 82 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/22/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/22/2020
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 [BSF27M]
5.bSample ID [BSF27L]
5.cSample ID [BP98ZN]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854295
Page 83 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Jan/26/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854296
Page 84 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Jan/26/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
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 [BRH0GN]
5.bSample ID [BSF1SC]
5.cSample ID [BSF1SD]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854297
Page 85 of 329
***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: 12262000 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:
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854298
Page 86 of 329
***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: 12262000 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 [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854299
Page 87 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854300
Page 88 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854301
Page 89 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/23/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854302
Page 90 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854303
Page 91 of 329
***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: 12262000 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:
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854304
Page 92 of 329
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854305
Page 93 of 329
***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: 12262000 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?
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854306
Page 94 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854307
Page 95 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854308
Page 96 of 329
***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: 12262000 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: [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854309
Page 97 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/20/2021
2.Erroneous Visit
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854310
Page 98 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854311
Page 99 of 329
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/15/2021
2.Erroneous Visit
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854312
Page 100 of 329
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/26/2021
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854313
Page 101 of 329
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854314
Page 102 of 329
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Mar/15/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854315
Page 103 of 329
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/15/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854316
Page 104 of 329
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 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/15/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGZ5W]
5.bSample ID [BRXW99]
5.cSample ID [BRXW9B]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854317
Page 105 of 329
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 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:
Mar/15/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGZ6J]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854318
Page 106 of 329
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/15/2021 10:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854319
Page 107 of 329
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854320
Page 108 of 329
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854321
Page 109 of 329
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12262000 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 [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854322
Page 110 of 329
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12262000 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?
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854323
Page 111 of 329
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854324
Page 112 of 329
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854325
Page 113 of 329
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854326
Page 114 of 329
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854327
Page 115 of 329
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854328
Page 116 of 329
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854329
Page 117 of 329
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854330
Page 118 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EV
ENT 1  Chest pain  Nov/19/2020 UNK:
UNK NO
End Date Time:
Nov/21/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EV
ENT 2  Arrhythmia  Nov/19/2020 UNK:
UNK NO
End Date Time:
Nov/21/2020 UNK:UNK
 Repeating
Pages
 3.ADVERSE EV
ENT 3  COVID-19  Dec/20/2020 UNK:
UNK NO
End Date Time:
Jan/14/2021 UNK:UNK
 Repeating
Pages
 4.ADVERSE EV
ENT 4  Dysuria  Feb/16/2021 UNK:
UNK YES  Repeating
Pages
 5.ADVERSE EV
ENT 5  Pain at the injectio
n site Mar/15/2021 UNK:
UNK YES  Repeating
Pages
 6.ADVERSE EV
ENT 6  Muscle pain  Mar/16/2021 UNK:
UNK YES  Repeating
Pages
 7.ADVERSE EV
ENT 7  Fever 38.8 C  Mar/16/2021 UNK:
UNK YES  Repeating
Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854331
Page 119 of 329
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 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)[Chest pain]
4.Start Date Time: Nov/19/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/21/2020 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:
[Emotional stress]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854332
Page 120 of 329
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854333
Page 121 of 329
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 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)[Arrhythmia]
4.Start Date Time: Nov/19/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/21/2020 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:
[Emotional stress]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854334
Page 122 of 329
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854335
Page 123 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[COVID-19]
4.Start Date Time: Dec/20/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/14/2021 UNK:UNK
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
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854336
Page 124 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021004692]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854337
Page 125 of 329
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dysuria]
4.Start Date Time: Feb/16/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[urinary bacterial infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854338
Page 126 of 329
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854339
Page 127 of 329
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pain at the injection site]
4.Start Date Time: Mar/15/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854340
Page 128 of 329
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854341
Page 129 of 329
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Muscle pain]
4.Start Date Time: Mar/16/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854342
Page 130 of 329
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854343
Page 131 of 329
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fever 38.8 C]
4.Start Date Time: Mar/16/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854344
Page 132 of 329
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854345
Page 133 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categor
yMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
 1.          Repeating
Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854346
Page 134 of 329
***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: 12262000 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[ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854347
Page 135 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854348
Page 136 of 329
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854349
Page 137 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854350
Page 138 of 329
***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: 12262000 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?
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854351
Page 139 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854352
Page 140 of 329
***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: 12262000 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?
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854353
Page 141 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854354
Page 142 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854355
Page 143 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/22/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854356
Page 144 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854357
Page 145 of 329
***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: 12262000 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: [ ]
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854358
Page 146 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/23/2020
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854359
Page 147 of 329
***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: 12262000 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
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854360
Page 148 of 329
***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: 12262000 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-18-2021 11:00:46 (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.
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854361
Page 149 of 329
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormOct-01-2020 16:07:36 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b    
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854362
Page 150 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormNov-23-2020 17:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854363
Page 151 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Nov-23-2020 17:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854364
Page 152 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Nov-23-2020 17:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854365
Page 153 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Nov-23-2020 17:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854366
Page 154 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Nov-23-2020 17:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854367
Page 155 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Nov-23-2020 17:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854368
Page 156 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Nov-23-2020 17:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854369
Page 157 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
7Nov-23-2020 17:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854370
Page 158 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
8Nov-23-2020 17:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854371
Page 159 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
9Nov-23-2020 17:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854372
Page 160 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormJan-07-2021 16:52:27 (UTC-03:00) City of
Buenos Aires
FormDec-22-2020 14:55:03 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854373
Page 161 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Jan-07-2021 16:52:27 (UTC-03:00) City of
Buenos Aires
1Dec-22-2020 14:55:03 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854374
Page 162 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Jan-07-2021 16:52:27 (UTC-03:00) City of
Buenos Aires
2Dec-22-2020 14:55:03 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854375
Page 163 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Jan-07-2021 16:52:27 (UTC-03:00) City of
Buenos Aires
3Dec-22-2020 14:55:03 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854376
Page 164 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Jan-07-2021 16:52:27 (UTC-03:00) City of
Buenos Aires
4Dec-22-2020 14:55:03 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854377
Page 165 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Jan-07-2021 16:52:27 (UTC-03:00) City of
Buenos Aires
5Dec-22-2020 14:55:03 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854378
Page 166 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Jan-07-2021 16:52:27 (UTC-03:00) City of
Buenos Aires
6Dec-22-2020 14:55:03 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854379
Page 167 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
7Jan-07-2021 16:52:27 (UTC-03:00) City of
Buenos Aires
7Dec-22-2020 14:55:03 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854380
Page 168 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
8Jan-07-2021 16:52:27 (UTC-03:00) City of
Buenos Aires
8Dec-22-2020 14:55:03 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854381
Page 169 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
9Jan-07-2021 16:52:27 (UTC-03:00) City of
Buenos Aires
9Dec-22-2020 14:55:03 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854382
Page 170 of 329
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormMar-15-2021 11:41:09 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854383
Page 171 of 329
***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: 12262000 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-18-2021 11:00:46 (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-16-2021 16:47:11 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Mar-16-2021 11:48:12 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-15-2021 11:37:35 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854384
Page 172 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Cristiano
Zerbini Approved Mar-04-2021 10:33:13 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-24-2021 08:49:57 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Feb-12-2021 16:41:54 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-27-2021 08:31:12 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Jan-23-2021 08:24:58 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854385
Page 173 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-23-2020 13:53:08 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Nov-12-2020 23:01:35 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854386
Page 174 of 329
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 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
Oct-01-2020 16:06:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-01-2020 16:06:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854387
Page 175 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-01-2020 16:06:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/1/2020Initial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854388
Page 176 of 329
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-01-2020 16:06:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12262000Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-01-2020 16:06:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1968Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-01-2020 16:07:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-01-2020 16:07:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR O
F SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-01-2020 16:07:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854389
Page 177 of 329
***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: 12262000 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-01-2020 16:07:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854390
Page 178 of 329
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 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-01-2020 16:08:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-01-2020 16:08:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-01-2020 16:08:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854391
Page 179 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Oct-01-2020 16:09:25
(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
10
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-01-2020 16:09:25
(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
Oct-01-2020 16:09:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
obesityInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-01-2020 16:09:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-01-2020 16:09:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854392
Page 180 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.b
Date Location User Value Reason
Oct-01-2020 16:10:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:constipation
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-01-2020 16:10:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-01-2020 16:10:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
constipationInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-01-2020 16:10:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-01-2020 16:10:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854393
Page 181 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.c
Date Location User Value Reason
Oct-01-2020 16:11:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:withdrawal of nasal b
asal cell cancer
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011Initial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0854394
Page 182 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.c Line/MH Number:
Date Location User Value Reason
Oct-01-2020 16:11:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-01-2020 16:11:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
withdrawal of nasal basal cell canc
erInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-01-2020 16:11:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2011Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-01-2020 16:11:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
1.d
Date Location User Value Reason
Oct-01-2020 16:12:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:Hepatic steato
sis
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854395
Page 183 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.d Line/MH Number:
Date Location User Value Reason
Oct-01-2020 16:12:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-01-2020 16:12:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Hepatic steatosisInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-01-2020 16:12:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-01-2020 16:12:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854396
Page 184 of 329
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-01-2020 16:12:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
The subject is NOT known to be H
IV POSITIVEInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854397
Page 185 of 329
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Oct-01-2020 16:13:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-01-2020 16:13:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
88.5Initial Entry
3. Unit:
Date Location User Value Reason
Oct-01-2020 16:13:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-01-2020 16:13:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
165.3Initial Entry
5. Unit:
Date Location User Value Reason
Oct-01-2020 16:13:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0854398
Page 186 of 329
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Oct-01-2020 16:13:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.4Initial Entry
7.a
Date Location User Value Reason
Oct-01-2020 16:13:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Locati
on::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-01-2020 16:13:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-01-2020 16:13:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-01-2020 16:13:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854399
Page 187 of 329
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-01-2020 16:13:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854400
Page 188 of 329
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-01-2020 16:13:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-01-2020 16:13:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-01-2020 16:13:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-01-2020 16:13:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-01-2020 16:13:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854401
Page 189 of 329
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-01-2020 16:13:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-01-2020 16:13:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-01-2020 16:13:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-01-2020 16:13:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854402
Page 190 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-01-2020 16:14:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-01-2020 16:14:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
102823Initial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854403
Page 191 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 17:38:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 17:38:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020 17:38:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020 17:38:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP7XSGInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-01-2020 17:38:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP7XSGInitial Entry
5.b
Date Location User Value Reason
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854404
Page 192 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-01-2020 17:38:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLC0MFInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-01-2020 17:38:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLC0MFInitial Entry
5.c
Date Location User Value Reason
Oct-01-2020 17:39:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLC0MGInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-01-2020 17:39:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLC0MGInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854405
Page 193 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020 07:54:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020 07:54:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020 07:54:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-02-2020 07:54:05
(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-02-2020 07:54:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020 07:54:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP7XSTInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854406
Page 194 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a Sample ID
Date Location User Value Reason
Oct-02-2020 07:54:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP7XSTInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854407
Page 195 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-01-2020 16:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-01-2020 16:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-01-2020 16:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-01-2020 16:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/1/2020 13:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-01-2020 16:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854408
Page 196 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Oct-01-2020 16:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-01-2020 16:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-01-2020 16:15:27
(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
Oct-01-2020 16:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854409
Page 197 of 329
***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: 12262000 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
Oct-01-2020 16:15:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854410
Page 198 of 329
***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: 12262000 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-22-2020 14:38:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854411
Page 199 of 329
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date:
Date Location User Value Reason
Oct-22-2020 14:38:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
2.a
Date Location User Value Reason
Oct-22-2020 14:38:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.5
Temperature Unit: C
Temperature Locati
on::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-22-2020 14:38:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-22-2020 14:38:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-22-2020 14:38:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0854412
Page 200 of 329
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Oct-22-2020 14:38:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854413
Page 201 of 329
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-22-2020 14:38:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-22-2020 14:38:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-22-2020 14:38:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-22-2020 14:38:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-22-2020 14:38:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-22-2020 14:38:55
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854414
Page 202 of 329
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires Sponsor-Define
d Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-22-2020 14:38:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-22-2020 14:38:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-22-2020 14:38:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854415
Page 203 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 17:45:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 17:45:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 17:45:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 17:45:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-22-2020 17:45:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020 17:45:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR6NM1Initial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854416
Page 204 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 17:45:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR6NM1Initial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854417
Page 205 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-22-2020 14:39:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-22-2020 14:39:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-22-2020 14:39:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-22-2020 14:39:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/22/2020 10:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-22-2020 14:39:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-22-2020 14:39:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854418
Page 206 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
7. Route:
Date Location User Value Reason
Oct-22-2020 14:39:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-22-2020 14:39:14
(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
Oct-22-2020 14:39:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854419
Page 207 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-23-2020 17:03:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/23/2020Initial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854420
Page 208 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-24-2020 08:47:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-24-2020 08:47:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-24-2020 08:48:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-24-2020 08:47:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-24-2020 08:47:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/23/2020Initial Entry
5.a
Date Location User Value Reason
Nov-24-2020 08:48:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2XX7Initial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854421
Page 209 of 329
***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: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a Sample ID
Date Location User Value Reason
Nov-24-2020 08:48:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS2XX7Initial Entry
5.b
Date Location User Value Reason
Nov-24-2020 08:48:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2XX6Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-24-2020 08:48:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS2XX6Initial Entry
5.c
Date Location User Value Reason
Nov-24-2020 08:48:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR60DYInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-24-2020 08:48:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR60DYInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0854422
Page 210 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-20-2021 04:22:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Jan-19-2021 10:34:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Answered Data updated.
Jan-19-2021 06:54:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Opened DM: Kindly consider
to update missing
HOSPITALIZATION
DETAILS form or else
clarify. Thank you.
Nov-24-2020 16:16:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-24-2020 09:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please review
and update as
appropriate.
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-23-2020 17:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the
Signs and Symptoms
form is missing.
Please review and
update as appropriate.
Nov-23-2020 17:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date of
Collection in both
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854423
Page 211 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nasal Swab Self and
Nasal Swab are
missing. Please review
and update as
appropriate.
Nov-23-2020 17:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/23/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-23-2020 17:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854424
Page 212 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/23/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/21/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Dec-22-2020 14:53:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolved
:
Nov/26/2020New Information
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0854425
Page 213 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Buenos Aires
4.a Was symptom present?
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom P
resent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0854426
Page 214 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4.c Symptoms:
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAINInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0854427
Page 215 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Symptom
Present:YES
4.e Symptoms:
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms
:NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0854428
Page 216 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:YESInitial Entry
4.g Symptoms:
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0854429
Page 217 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4.i
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-23-2020 17:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854430
Page 218 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-24-2020
04:55:41
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1
: ClosedNo Data Issue
Nov-24-2020
04:22:25
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1
: Opene
dDMW6050491;Actual
Date of Collection is
not expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or
clarify
Nov-23-2020
17:05:28
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data E
ntry:
Not App
licableInitial Entry
2. Specimen Type:
Date Location User ValueReason
Nov-24-2020
04:55:41
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedNo Data Issue
Nov-24-2020
04:22:25
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW6061633;Specimen
Type is not expected to
be Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Nov-23-2020
17:05:28
(UTC-03:00)ACV0PFEINFP6000  Data
Entry
:Initial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0854431
Page 219 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
City of
Buenos AiresNot A
pplica
ble
3. Specimen Collection Location:
Date Location User ValueReason
Nov-24-2020
04:55:41
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedNo Data Issue
Nov-24-2020
04:22:25
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW6052220;Specimen
Collection Location is
not expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Nov-23-2020
17:05:28
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Not A
pplica
bleInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-23-2020 17:05:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Device Type:
Date Location User Value Reason
Nov-23-2020 17:05:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Trade Name:
Date Location User Value Reason
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0854432
Page 220 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-24-2020
04:55:41
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
ClosedNo Data Issue
Nov-24-2020
04:22:25
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
OpenedDMW6080665;Trade
Name is not expected
to be Unknown or
Not Applicable.
Please review and
update appropriately
or clarify
Nov-23-2020
17:05:28
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data En
try:
Not App
licableInitial Entry
7. Test Result:
Date Location User Value Reason
Nov-24-2020
04:55:41
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
ClosedNo Data Issue
Nov-24-2020
04:22:25
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
OpenedDMW6089168;Test
Result is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or
clarify
Nov-23-2020
17:05:28
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Ent
ry:
Not Appli
cableInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0854433
Page 221 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Nov-23-2020 17:05:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Nov-23-2020 17:05:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854434
Page 222 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-24-2020 16:16:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-24-2020 16:16:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-24-2020 16:16:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-24-2020 16:16:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
collected swab on site, recorded at
swab pfeInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854435
Page 223 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-24-2020 16:16:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-24-2020 16:16:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-24-2020 16:16:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-24-2020 16:16:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-24-2020 16:16:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/23/2020Initial Entry
5.a
Date Location User Value Reason
Nov-24-2020 16:16:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR60F6Initial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854436
Page 224 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.a Sample ID
Date Location User Value Reason
Nov-24-2020 16:16:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR60F6Initial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0854437
Page 225 of 329
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Not Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.a
Date Location User Value Reason
Nov-23-2020 17:05:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-23-2020 17:05:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-23-2020 17:05:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Jan-19-2021 10:32:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:EMERGENCY
ROOM
Occurrence of
Visits or Conta
cts:YES
Number of Vis
its or Contacts
:
1New Information
Nov-23-2020 17:05:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practition
er:EMERGEN
CY ROOMInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0854438
Page 226 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Not Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Occurrence of Vis
its or Contacts:NO
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-23-2020 17:05:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-19-2021 10:32:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1New Information
Nov-23-2020 17:05:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Nov-23-2020 17:05:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Contac
ts:NOInitial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0854439
Page 227 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Not Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262000 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-23-2020 17:05:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-23-2020 17:05:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Nov-23-2020 17:05:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner
:URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-23-2020 17:05:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-23-2020 17:05:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Nov-23-2020 17:05:49
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae406f\Final\Final On: 01-Apr-2021 05:39 (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-2021-5683-0854440
Page 228 of 329
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/23/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Not Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Inves
…[truncated]