Document text
Page 1 of 177
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840632
Page 2 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/21/2020
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840633
Page 3 of 177
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11561015]
2.Birth Date: /1994
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840634
Page 4 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/21/2020
2.Erroneous Visit
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840635
Page 5 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840636
Page 6 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840637
Page 7 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Seafood Allergy]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840638
Page 8 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/21/2020
2.Weight: [69.1]
3.Unit: kg
4.Height: [171.8]
5.Unit: cm
6.Body Mass Index: [23.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840639
Page 9 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/21/2020
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:
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840640
Page 10 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/21/2020
2.Randomization Number: [61147]
3.Randomization Group: [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840641
Page 11 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/21/2020
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 [BP1856]
5.bSample ID [BP1857]
5.cSample ID [BP1858]
5.dSample ID [BPHRXN]
5.eSample ID [BPHRXP]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840642
Page 12 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/21/2020
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 [BP1859]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840643
Page 13 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/21/2020 16:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840644
Page 14 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840645
Page 15 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840646
Page 16 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840647
Page 17 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/28/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: POSITIVE
Not Done:
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840648
Page 18 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/28/2020
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 [BP18SR]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840649
Page 19 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was
ObservedNot Done Comments
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840650
Page 20 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?Not Done Comments
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840651
Page 21 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840652
Page 22 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/26/2020
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 [BR69NC]
5.bSample ID [BRZPRZ]
5.cSample ID [BRZPS0]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840653
Page 23 of 177
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840654
Page 24 of 177
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840655
Page 25 of 177
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840656
Page 26 of 177
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840657
Page 27 of 177
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840658
Page 28 of 177
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840659
Page 29 of 177
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840660
Page 30 of 177
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840661
Page 31 of 177
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840662
Page 32 of 177
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840663
Page 33 of 177
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840664
Page 34 of 177
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840665
Page 35 of 177
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840666
Page 36 of 177
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840667
Page 37 of 177
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840668
Page 38 of 177
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840669
Page 39 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Sep/28/2020
2.Phase of Disposition: VACCINATION
3.Status: PREGNANCY
4.Specify Status: [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840670
Page 40 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840671
Page 41 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840672
Page 42 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840673
Page 43 of 177
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 EXPOSURE DURI
NG PREGNANCY Aug/21/20
20 12:25 YES Repeating
Pages
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840674
Page 44 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[EXPOSURE DURING PREGNANCY]
4.Start Date Time: Aug/21/2020 12:25
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840675
Page 45 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[THERE IS NOT AN UNDERLYING
CAUSE. THIS EVENT IS A STANDARD
PREGNANCY.]Comments
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840676
Page 46 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
10.Latest Action Taken with
Study Treatment:DRUG WITHDRAWN
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:UNKNOWN Comments
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840677
Page 47 of 177
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840678
Page 48 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840679
Page 49 of 177
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840680
Page 50 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: //
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840681
Page 51 of 177
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840682
Page 52 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840683
Page 53 of 177
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840684
Page 54 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840685
Page 55 of 177
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840686
Page 56 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840687
Page 57 of 177
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840688
Page 58 of 177
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840689
Page 59 of 177
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840690
Page 60 of 177
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840691
Page 61 of 177
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840692
Page 62 of 177
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840693
Page 63 of 177
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840694
Page 64 of 177
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840695
Page 65 of 177
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840696
Page 66 of 177
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840697
Page 67 of 177
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840698
Page 68 of 177
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840699
Page 69 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/18/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840700
Page 70 of 177
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840701
Page 71 of 177
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840702
Page 72 of 177
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840703
Page 73 of 177
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840704
Page 74 of 177
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840705
Page 75 of 177
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840706
Page 76 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/28/2020
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840707
Page 77 of 177
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840708
Page 78 of 177
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Hector
Rodriguez Approved Feb-19-2021 12:16:38 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840709
Page 79 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormAug-21-2020 17:05:42 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840710
Page 80 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-28-2020 17:30:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Done
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840711
Page 81 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Sep-28-2020 17:30:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Done
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840712
Page 82 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Sep-28-2020 17:30:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Done
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840713
Page 83 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Sep-28-2020 17:30:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Done
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840714
Page 84 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Sep-28-2020 17:30:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Done
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840715
Page 85 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Sep-28-2020 17:30:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Done
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840716
Page 86 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Sep-28-2020 17:30:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Done
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840717
Page 87 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
7Sep-28-2020 17:30:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Done
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840718
Page 88 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
8Sep-28-2020 17:30:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Done
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840719
Page 89 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
9Sep-28-2020 17:30:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Done
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840720
Page 90 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
10Sep-28-2020 17:30:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Done
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840721
Page 91 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
11Sep-28-2020 17:30:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Done
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840722
Page 92 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Oct-05-2020 13:32:59 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840723
Page 93 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
9Oct-28-2020 18:36:41 (UTC-05:00)
Eastern Time (US & Canada)
9Oct-05-2020 13:33:20 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840724
Page 94 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
13Nov-11-2020 17:37:13 (UTC-05:00)
Eastern Time (US & Canada)Hector Aguilar
13Oct-05-2020 13:33:28 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840725
Page 95 of 177
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Hector
Rodriguez Approved Feb-19-2021 12:16:38 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
Hector
Aguilar N/A Feb-18-2021 17:08:06 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Nov-16-2020 15:33:20 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840726
Page 96 of 177
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840727
Page 97 of 177
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-21-2020
17:03:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-21-2020
17:03:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840728
Page 98 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-21-2020
17:03:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/21/2020Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840729
Page 99 of 177
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-06-2020
07:46:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedEvent recorded in Inform
Oct-05-2020
13:39:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
Answere
dTHIS HAS NOW BEEN
ENTERED
Oct-03-2020
09:30:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
OpenedSAE
RECON:AER#2020377626
a NON SERIOUS
EXPOSURE DURING
PREGNANCY
event(Onset
date:29Sep2020)was
reported to Pfizer Safety
but missing in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Aug-21-2020
17:03:17ACV0PFEINFP6000 auto calc
(autocalc)Data En
try:Item copied from previous
form
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0840730
Page 100 of 177
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time
(US &
Canada)1156101
5
2. Birth Date:
Date Location User Value Reason
Aug-21-2020
17:03:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1994Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-21-2020
17:04:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-21-2020
17:04:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840731
Page 101 of 177
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-21-2020
17:04:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BLACK OR AFRIC
AN AMERICANInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840732
Page 102 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-21-2020
17:04:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Aug/21/2020Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840733
Page 103 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-21-2020
17:05:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Aug/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-21-2020
17:05:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-21-2020
17:05:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
COMPLETEDInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840734
Page 104 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Aug-21-2020
17:07:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Seafood
Allergy
Start Date: UNK/U
NK/201
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-21-2020
17:07:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-05-2020
16:01:09
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Giselle Castillo Query 1: Closed Response
satisfies query
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840735
Page 105 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(US & Canada)
Oct-05-2020
13:38:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answer
edTHIS HAS
NOW BEEN
ENTERED
Oct-04-2020
18:37:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Opened Pregnancy is
to be reported
as an AE
regardless of
whether it is
associated
with an AE,
per CRF
completion
requirements
section
8.47.2.5.
Please update
accordingly.
Aug-21-2020
17:07:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Hector Aguilar Data Entry:
Seafood AllergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-21-2020
17:07:24
(UTC-05:00)ACV0PFEINFP6000 Hector
AguilarData Entry:
UNK/UNK/2010Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840736
Page 106 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)
1.a Ongoing:
Date Location User Value Reason
Aug-21-2020
17:07:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840737
Page 107 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Aug-21-2020
17:08:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Aug/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-21-2020
17:08:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
69.1Initial Entry
3. Unit:
Date Location User Value Reason
Aug-21-2020
17:08:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840738
Page 108 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-21-2020
17:08:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
171.8Initial Entry
5. Unit:
Date Location User Value Reason
Aug-21-2020
17:08:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-21-2020
17:08:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.4Initial Entry
7.a
Date Location User Value Reason
Aug-21-2020
17:08:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Record Ide
ntifier::1
Temperatu
re:97.3Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840739
Page 109 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-21-2020
17:08:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-21-2020
17:08:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
97.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-21-2020
17:08:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
FInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840740
Page 110 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7.a Temperature Location:
Date Location User Value Reason
Aug-21-2020
17:08:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840741
Page 111 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-21-2020
17:08:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-21-2020
17:08:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-21-2020
17:08:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Aug/21/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840742
Page 112 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-21-2020
17:08:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-21-2020
17:08:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-21-2020
17:08:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840743
Page 113 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-21-2020
17:08:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-21-2020
17:08:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-21-2020
17:08:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NEGATIVEInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840744
Page 114 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-21-2020
17:08:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Aug/21/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-21-2020
17:08:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
61147Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840745
Page 115 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020
17:09:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020
17:09:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020
17:10:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-21-2020
17:09:51
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840746
Page 116 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-21-2020
17:09:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YES
Date of Collection
:
Aug/21/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020
17:10:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sample ID
:BP185
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020
17:10:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BP1856Initial Entry
5.b
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840747
Page 117 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-21-2020
17:10:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sample ID
:BP185
7Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-21-2020
17:10:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BP1857Initial Entry
5.c
Date Location User Value Reason
Aug-21-2020
17:10:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sample ID
:BP185
8Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840748
Page 118 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Aug-21-2020
17:10:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BP1858Initial Entry
5.d
Date Location User Value Reason
Aug-21-2020
17:10:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sample I
D:BPHRX
NInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-21-2020
17:10:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BPHRXNInitial Entry
5.e
Date Location User Value Reason
Aug-21-2020
17:10:39ACV0PFEINFP6000 Hector
AguilarData Entry:
Sample I BPHRXInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840749
Page 119 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)D: P
5.e Sample ID
Date Location User Value Reason
Aug-21-2020
17:10:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BPHRXPInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840750
Page 120 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020
17:10:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020
17:10:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020
17:11:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-21-2020
17:10:56
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840751
Page 121 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-21-2020
17:10:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YES
Date of Collection
:
Aug/21/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020
17:11:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sample ID
:BP185
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020
17:11:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BP1859Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840752
Page 122 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-21-2020
17:09:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-21-2020
17:09:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-21-2020
17:09:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840753
Page 123 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-21-2020
17:09:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Aug/21/2020 16:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-21-2020
17:09:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-21-2020
17:09:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-21-2020
17:09:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840754
Page 124 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-21-2020
17:09:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-21-2020
17:09:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840755
Page 125 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-24-2020
10:11:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTE
D FOR THIS SUBJ
ECTTranscription
Error
Aug-21-2020
17:09:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YES - REACTOGE
NICITY E-DIARY
COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840756
Page 126 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020
08:24:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed As per site
confirmation -
updated PD
tracker
Sep-29-2020
09:51:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Hector Aguilar Query 2: Answer
edsubject was/is
out of window
Sep-29-2020
05:09:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened PDQ: DOV at
this visit is out
of window (15
day) from DOV
(21/Aug/2020)
at V1D1VX1L.
Please either
update DOV or
confirm
whether visit is
out of window
due to
temporary
delay of
vaccination/
else provide
details as
appropriate.
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840757
Page 127 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-28-2020
17:26:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Hector Aguilar Data Entry:
Sep/28/2020Initial Entry
Sep-28-2020
03:57:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Sep-27-2020
14:01:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answer
edVISIT HAS
NOT BEEN
COMPLETED
Sep-26-2020
06:36:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly
review and
complete ‘Date
of Visit, Nasal
Swab,
Pregnancy Test,
Vaccination,
Vital Signs'
forms at this
visit. Thank
you.
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840758
Page 128 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-28-2020
17:26:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sep/28/2020Initial Entry
2.a
Date Location User Value Reason
Sep-28-2020
17:26:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Record Ide
ntifier::1
Temperatu
re:98.2
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-28-2020
17:26:34
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Hector
AguilarData Entry:
1Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840759
Page 129 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-28-2020
17:26:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-28-2020
17:26:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-28-2020
17:26:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840760
Page 130 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-28-2020
17:26:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-04-2020
18:36:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Query placed
on a different
form.
Oct-01-2020
14:46:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Pregnancy is to
be reported as
an AE
regardless of
whether it is
associated with
an AE, per
CRF
completion
requirements
section
8.47.2.5.
Please update
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840761
Page 131 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
accordingly.
Sep-28-2020
17:26:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-28-2020
17:26:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sep/28/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-28-2020
17:26:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-28-2020
17:26:42
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840762
Page 132 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada)
6.a
Date Location User Value Reason
Sep-28-2020
17:26:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: POSITIVE
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-28-2020
17:26:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-28-2020
17:26:42
(UTC-05:00)ACV0PFEINFP6000 Hector
AguilarData Entry:
Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840763
Page 133 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)
6.a Result:
Date Location User Value Reason
Sep-29-2020
05:06:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Closed per
SITE response,
added to PD
tracker
Sep-28-2020
17:33:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarQuery 1: Answered subject had a
positive
pregnancy test
on visit 2
(28sep2020).
Per PI, based
on exclusion
11, subject will
not receive
treatment (2nd
vaccine).
Sep-28-2020
17:26:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Lab result is
“Positive”, but
subject has
been
vaccinated.
Please review
and update as
appropriate.
Else explain.
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840764
Page 134 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-28-2020
17:26:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
POSITIVEInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840765
Page 135 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020
18:40:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020
18:40:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020
18:40:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-28-2020
18:40:01
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840766
Page 136 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-28-2020
18:40:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YES
Date of Collection
:
Sep/28/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020
18:40:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sample ID
:BP18S
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-28-2020
18:40:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BP18SRInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840767
Page 137 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-28-2020
17:30:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020
17:30:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020
17:30:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840768
Page 138 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-28-2020
17:30:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-28-2020
17:30:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-28-2020
17:30:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Sep-28-2020
17:30:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Not DoneInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840769
Page 139 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
8. Actual Dose:
Date Location User Value Reason
Sep-28-2020
17:30:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Sep-28-2020
17:30:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-28-2020
17:30:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-28-2020
17:30:47ACV0PFEINFP6000 Hector
AguilarData Entry:
Not DoneInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840770
Page 140 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840771
Page 141 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-26-2020
16:05:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Oct/26/2020Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840772
Page 142 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020
18:24:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020
18:24:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-26-2020
18:24:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-26-2020
18:24:10
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840773
Page 143 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-26-2020
18:24:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
YES
Date of Collection
:
Oct/26/2020Initial Entry
5.a
Date Location User Value Reason
Oct-26-2020
18:24:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sample ID
:BR69N
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-26-2020
18:24:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BR69NCInitial Entry
5.b
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840774
Page 144 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-27-2020
09:41:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sample ID
:BRZPR
ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-27-2020
09:41:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BRZPRZInitial Entry
5.c
Date Location User Value Reason
Oct-27-2020
09:41:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sample ID
:BRZPS
0Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840775
Page 145 of 177
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Oct-27-2020
09:41:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
BRZPS0Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840776
Page 146 of 177
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-28-2020
17:34:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Sep/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-28-2020
17:34:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-14-2020
05:21:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Cl
osedResponse satisfies
query
Nov-13-2020
16:09:39
(UTC-05:00)ACV0PFEINFP6000 Query 2: An
swered"Disposition Form
Statuses for
Pregnancies: If
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840777
Page 147 of 177
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time
(US & Canada)exposure during
pregnancy is the
reason for treatment
discontinuation:
Latest Action Taken
with Study Treatment
= Drug Withdrawn
Disposition status =
Pregnancy"
Nov-12-2020
01:16:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Re
issued:Open
edDM 1 : Please review
and consider to update
the status to
ADVERSE EVENT .
Else,clarify.
Nov-11-2020
14:32:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: An
sweredTHIS REQUEST IS
STILL PENDING
CLARIFICATION
FROM THE STUDY
TEAM
Nov-07-2020
13:37:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Re
issued:Open
edDM Query: Please
update the status to
AE as it is the correct
option.
Oct-27-2020
07:29:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Re
issued:Cand
idateAdded to DM Ops
Tracker.
Oct-26-2020
16:20:45ACV0PFEINFP6000 Query 2: An
sweredTHIS PREGNANCY
DOES NOT HAVE
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (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-2021-5683-0840778
Page 148 of 177
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time
(US & Canada)AN ASSOCIATED
ADVERSE EVENT.
IT IS ONLY
REPORTED FOR
TRACKING
PURPOSES.
PLEASE CLOSE
THIS QUERY.
Oct-26-2020
07:50:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Re
issued:Open
edDM: Per CCG 'Select
Adverse Event if this
is the primary reason
the Participant was
discontinued from
study. This
information must be
consistent with the
data on the Adverse
Event page' Kindly
review and update.
Oct-16-2020
08:31:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Re
issued:Cand
idateStatus needs to be
updated to AE.
Oct-15-2020
14:39:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Hector Aguilar Query 2: An
sweredTHE REASON FOR
END OF
TREATMENT WAS
AE(PREGNANCY)
Oct-14-2020
12:29:09ACV0PFEINFP6000 Query 2: Re
issued:OpenDM1: As per CRF CR
Section 8.55.2, If
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840779
Page 149 of 177
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time
(US & Canada)ed there are two or more
reasons for
withdrawal and an
adverse event is one
of them, the adverse
event is considered
the primary reason.
Kindly update data
accordingly, else
clarify, Thank you.
Oct-12-2020
15:50:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: An
sweredTHAT IS BECAUSE
THE TREATMENT
DISCONTINUATION
FORM HAS AN
OPTION OF
"PREGNANCY."
Oct-12-2020
15:50:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Cl
osedClose Auto Query
Oct-12-2020
15:50:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Op
enedResponse to "Status"
is PREGNANCY but
"Specify Status" is
Provided.
Oct-12-2020
13:30:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Op
enedDM: The Adverse
Event Action Taken is
DRUG
WITHDRAWN but
reason for treatment
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0840780
Page 150 of 177
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
discontinuation is not
reported as
ADVERSE EVENT
or DEATH. Please
review and clarify.
Oct-12-2020
13:30:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Cl
osedIncorrect Query
Oct-12-2020
13:27:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Op
enedDM: As per Adverse
Event form, AE was
the reason for
discontinued from the
study. However
DISPOSITION -
TREATMENT and
DISPOSITION -
FOLLOW-UP do not
have the Status
updated as Adverse
Event. Please review
and update as
appropriate.
Sep-28-2020
17:34:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Hector Aguilar Data Entry
:
PREGNAN
CYInitial Entry
4. Specify Status:
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840781
Page 151 of 177
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-12-2020
15:50:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription
Error
Oct-12-2020
15:50:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
THAT IS BECA
USE THE TREA
TMENT DISCO
NTINUATION F
ORM HAS AN O
PTION OF "PRE
GNANCY."Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840782
Page 152 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-05-2020
13:32:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840783
Page 153 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Oct-05-2020
13:32:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-05-2020
13:32:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-05-2020
13:32:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
EXPOSURE DURI
NG PREGNANCYInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840784
Page 154 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-12-2020
16:15:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: ClosedResponse satisfies query
Nov-12-2020
09:31:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Hector Aguilar Query 2
: Answe
redIN V1 VISIT, A
PREGNANCY TEST WAS
PERFROMED AND
RESULTS WERE
NEGATIVE. IT HAS
BEEN DOCUMENTED IN
V1
Nov-12-2020
04:51:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Balaji Prabu R Query 2
: Opene
dAs per completion
guidelines version 10.0, If
conception occurred prior to
vaccination 1, time to be
recorded as UNK:UNK.
Please review and update as
appropriate. Else clarify.
Nov-11-2020
17:36:29
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Hector Aguilar Query 1
: Delete
dNew Information
Nov-11-2020
17:36:29
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Hector Aguilar Data E
ntry:
Aug/21/
2020 12
:25New Information
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840785
Page 155 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Canada)
Nov-10-2020
02:21:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Cand
idateFor Clinical review
Nov-09-2020
14:56:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redI AM NOT QUITE SURE
THAT WE UNDERSTAND
YOUR REQUEST. WE DO
NOT HAVE AN EDP
GUIDANCE DOCUMENT
TO REFERENCE. THE
LMP IS NOT
NECESSARILY THE
DATE OF CONCEPTION,
AND IT IS NOT
POSSIBLE TO KNOW IF
THE SUBJECT WAS
INDEED PREGNANT AT
DOSE 1.
Nov-06-2020
07:55:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Opene
dSAE
RECON:AER#2020377626,
the onset date was reported
as 28Sep2020 in both
database. However,based on
EDP guidance,the date of
onset = Vax1 = 21Aug2020.
The participant was
pregnant at enrollment LMP
= 04Aug2020. Please
confirm and update both
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0840786
Page 156 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
database.
Oct-05-2020
13:32:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
Sep/28/
2020 12
:25Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-05-2020
13:32:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-30-2020
14:40:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query 1:
ClosedOk. Thank you.
Oct-30-2020
12:13:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
AnsweredPLEASE HAVE
SOMEONE PROVIDE
GUIDANCE ON HOW
THEY WOULD LIKE
THE INTENSITY OF
AN EVENT THAT IS
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840787
Page 157 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
NOT AN ADVERSE
EVENTS TO BE
DETERMINED. WHEN
THIS GUIDANCE IS
RECEIVED WE WILL
GO AHEAD AND
UPDATE.
Oct-29-2020
18:38:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query 1:
Reissued:
OpenedAppreciate the response.
Kindly revise the
following options stated
in the CRF CG section
8.50.5: Grace 1 = MILD
Grade 2 = MODERATE
Grade 3 = SEVERE
Grade 4 =
LIFE-THREATENING
Thank you.
Oct-28-2020
18:38:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
Answered"EDP DID NOT HAVE
AN ASSOCIATED AE.
PER SAE FORM JOB
AID, CERTAIN INFO
SHOULD BE LEFT
BLANK; I.E.,
SERIOUSNESS
CRITERIA, STATUS AT
LAST OBSERVATION."
Oct-28-2020
16:53:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query 1:
Reissued:
OpenedKindly revise CRF
completion guidelines
section 8.50.5. Toxicity
Grade. Please
consider/review intensity
grades defined in the
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840788
Page 158 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
table. Thank you.
Oct-17-2020
16:21:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
AnsweredEDP DID NOT HAVE
AN ASSOCIATED AE,
THERE IS NOT
TOXICITY/INTENSITY
TO PROVIDE. PER
SAE FORM JOB AID,
CERTAIN INFO
SHOULD BE LEFT
BLANK; I.E.,
SERIOUSNESS
CRITERIA, STATUS AT
LAST OBSERVATION.
Oct-13-2020
22:02:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query 1:
OpenedInformation on the
toxicity grade should be
provided. Please review
and update grading
accordingly.
Oct-05-2020
13:32:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
Not Appli
cableInitial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840789
Page 159 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-05-2020
13:32:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-05-2020
13:32:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-30-2020
14:54:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Katherine Puig Query 2: Closed Response
satisfies query
Oct-30-2020
12:14:49
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 auto query
(autoquery)Query 2: Answe
redChanged
Information
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840790
Page 160 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(US & Canada)
Oct-30-2020
12:14:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related
to study treatm
ent(s), this eve
nt is due to:
OTHER
If Other, spe
cify:
THERE I
S NOT A
N UNDE
RLYING
CAUSE.
THIS EV
ENT IS A
STANDA
RD PREG
NANCY.Changed
Information
Oct-30-2020
03:09:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opene
dDM: The
response for "Is
this event related
to study
treatment" Is
reported as 'Not
Related',
however
response for,
'Please indicate
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0840791
Page 161 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
what this event is
due to' is
missing. Kindly
review and
update.
Oct-29-2020
14:09:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Closed Thank you.
Oct-28-2020
18:36:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answe
redInitial Entry
Oct-28-2020
18:36:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
Oct-28-2020
18:36:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Oct-28-2020
16:47:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Reissu
ed:OpenedKindly, re-assess
if this adverse
event is related
to study
treatment and
record NOT
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840792
Page 162 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
RELATED or
RELATED.
Thank you.
Oct-17-2020
16:20:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answe
redEDP DID NOT
HAVE AN
ASSOCIATED
AE. PER SAE
FORM JOB
AID, CERTAIN
INFO SHOULD
BE LEFT
BLANK; I.E.,
SERIOUSNESS
CRITERIA,
STATUS AT
LAST
OBSERVATION.
ARE YOU
STATING THAT
CAUSALITY
MUST BE
ASSESSED?
Oct-13-2020
22:08:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Opene
dPer section
8.47.8. of CRF
completion
guidelines:
“Assess if this
adverse event is
related to study
treatment and
record NOT
RELATED or
RELATED”.
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840793
Page 163 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Please review
and update this
field accordingly.
Thank you
Oct-05-2020
13:33:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-12-2020
13:26:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Close
dMoving Query to
EOT form.
Oct-09-2020
15:16:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answ
eredCAN YOU
PLEASE
CLARIFY YOUR
REQUEST? THE
SUBJECT HAS
ALREADY HAD
THEIR EOT
FORM
COMPLETED.
Oct-09-2020
04:04:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Sandip
Namdeorao
SuryawanshiQuery 1: Reiss
ued:OpenedKindly update
adverse event on
end of treatment
on status. Else
clarify. Thank
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840794
Page 164 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
you.
Oct-08-2020
17:19:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Hector Aguilar Query 1: Answ
eredTHE SUBJECT
IS
DISCONTINUED
FROM IP DUE
TO AE,
HOWEVER, THE
SUBJECT
CONTINUES
FOR
FOLLOW-UP IN
THE STUDY
Oct-08-2020
09:58:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opene
dDM: The Adverse
Event Action
Taken is DRUG
WITHDRAWN
but reason for
treatment
discontinuation is
not reported as
ADVERSE
EVENT or
DEATH. Please
review and
clarify.
Oct-05-2020
13:32:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITH
DRAWNInitial Entry
11. Was a Concomitant Medication given?
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840795
Page 165 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-05-2020
13:32:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-05-2020
13:32:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-12-2020
07:00:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Nov-12-2020
02:10:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Related query
present
Nov-11-2020
18:44:31ACV0PFEINFP6000 Query 3: Answer
edNOT APP
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (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-2021-5683-0840796
Page 166 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time
(US & Canada)
Nov-11-2020
18:43:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened For AE
EXPOSURE
DURING
PREGNANCY:
Response to
"What was the
outcome of this
adverse event?"
is 'Unknown'
but End
Date/Time is
provided or "Is
the adverse
event still
ongoing?" is
marked "Yes".
Nov-11-2020
18:43:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNChanged
Information
Nov-11-2020
17:37:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answer
edInitial Entry
Nov-11-2020
17:37:27
(UTC-05:00)ACV0PFEINFP6000 Hector Aguilar Data Entry:
NOT RECOVE
RED/NOT RESInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840797
Page 167 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time
(US & Canada)OLVED
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840798
Page 168 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Nov-11-2020
17:37:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Hector Aguilar Data
Entry
:Initial Entry
Nov-11-2020
06:04:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Op
enedSAE RECON:
AER#2020377626, the
outcome in AE CRF was
reported as Not
Applicable.Based on the latest
EDP guidance, outcome
should be recorded as
UNKNOWN. Please confirm
and update accordingly.
Oct-30-2020
14:41:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query
1: Clo
sedThank you.
Oct-30-2020
12:11:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
d"EDP DID NOT HAVE AN
ASSOCIATED AE. PER SAE
FORM JOB AID, CERTAIN
INFO SHOULD BE LEFT
BLANK; I.E.,
SERIOUSNESS CRITERIA,
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840799
Page 169 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
STATUS AT LAST
OBSERVATION."
Oct-29-2020
18:31:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query
1: Rei
ssued:
Open
edAppreciate the response.
Kindly choose between the
following options stated in the
CRF CG: FATAL NOT
RECOVERED/NOT
RESOLVED
RECOVERED/RESOLVED
RECOVERED/RESOLVED
WITH SEQUELAE
RECOVERING/RESOLVING
UNKNOWN Thank you.
Oct-28-2020
18:34:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
d"EDP DID NOT HAVE AN
ASSOCIATED AE. PER SAE
FORM JOB AID, CERTAIN
INFO SHOULD BE LEFT
BLANK; I.E.,
SERIOUSNESS CRITERIA,
STATUS AT LAST
OBSERVATION."
Oct-28-2020
16:59:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query
1: Rei
ssued:
Open
edKindly review the CRF
completion guidelines section
8.50.12. "What was the
outcome of this adverse
event?" so this row is
recorded accordingly. Thank
you.
Oct-17-2020
16:21:10
(UTC-05:00)ACV0PFEINFP6000 Query
1: An
swereEDP DID NOT HAVE AN
ASSOCIATED AE. PER SAE
FORM JOB AID, CERTAIN
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840800
Page 170 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time
(US &
Canada)dINFO SHOULD BE LEFT
BLANK; I.E.,
SERIOUSNESS CRITERIA,
STATUS AT LAST
OBSERVATION.
Oct-13-2020
22:11:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query
1: Op
enedClinical_Per section 8.47.12.
of CRF completion
guidelines: “Record the
appropriate outcome of the
event in relation to the
Participant's status”. Please
review and update this field
accordingly. Thank you
Oct-05-2020
13:33:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-05-2020
13:32:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840801
Page 171 of 177
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021
17:08:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Feb/18/2021Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840802
Page 172 of 177
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-18-2021
17:08:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-18-2021
17:08:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-18-2021
17:08:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Participant is willin
g to return for Vacc
ination 3
Participant is:
eligible per loca
l/national recom
mendations and
confirmed to haInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840803
Page 173 of 177
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
ve received only
placebo at Vacci
nation 1/2
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840804
Page 174 of 177
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-18-2021
17:08:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
Feb/18/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-18-2021
17:08:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hector
AguilarData Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840805
Page 175 of 177
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject Status
Date Location User Value Reason
Sep-28-2020
17:34:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Aug-21-2020
17:08:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-21-2020
17:05:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Sep-28-2020
17:34:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/28/2020Initial Entry
Aug-21-2020
17:08:45ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/21/2020Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840806
Page 176 of 177
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
Aug-21-2020
17:05:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/21/2020Initial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840807
Page 177 of 177
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-15-2020
11:14:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to Enabl
eInitial Entry
090177e196ae30c6\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840808