Document text
Page 1 of 203
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925867
Page 2 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/17/2020
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925868
Page 3 of 203
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [11101271]
2.Birth Date: /1977
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925869
Page 4 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925870
Page 5 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925871
Page 6 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925872
Page 7 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[appendicitis]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[appendectomy]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[cesarean section]
Start Date: Jul/7/2010
Ongoing: NO
End Date:
Jul/7/2010
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[cesarean section]
Start Date: Nov/9/2018
Ongoing: NO
End Date:
Nov/9/2018
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925873
Page 8 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[bilateral salpingectomy]
Start Date: Nov/9/2018
Ongoing: NO
End Date:
Nov/9/2018
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925874
Page 9 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925875
Page 10 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Sep/29/2020 Comments
2.Weight: [61.7] Comments
3.Unit: kg Comments
4.Height: [165.0] Comments
5.Unit: cm Comments
6.Body Mass Index: [22.7] Comments
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.2] Comments
Unit: C Comments
Temperature Location: FOREHEAD Comments
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925876
Page 11 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925877
Page 12 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/29/2020 Comments
2.Randomization Number: [101399] Comments
3.Randomization Group: [ ] Comments
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925878
Page 13 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
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 [BPY0C9]
5.bSample ID [BRVHS3]
5.cSample ID [BRVHS4]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925879
Page 14 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
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 [BPY0GZ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925880
Page 15 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Sep/17/2020
Reason(s) for Temporary Delay of Vaccination
RECENT NON-STUDY VACCINATION
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/29/2020 10:12 Comments
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT Comments
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES Comments
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925881
Page 16 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925882
Page 17 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925883
Page 18 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Oct/20/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925884
Page 19 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/20/2020
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:
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925885
Page 20 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW9CB]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925886
Page 21 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/20/2020 09:43
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925887
Page 22 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/19/2020
2.Erroneous Visit
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925888
Page 23 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/19/2020
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 [BPW5BL]
5.bSample ID [BRVHX4]
5.cSample ID [BRVHX5]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925889
Page 24 of 203
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925890
Page 25 of 203
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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: [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925891
Page 26 of 203
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925892
Page 27 of 203
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925893
Page 28 of 203
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925894
Page 29 of 203
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925895
Page 30 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925896
Page 31 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925897
Page 32 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925898
Page 33 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925899
Page 34 of 203
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925900
Page 35 of 203
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Unplanned Assessments
1.Assessments
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925901
Page 36 of 203
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
1.ADVERSE EVE
NT 1 Headache Jan/7/2021 UNK:U
NK YES Repeating
Pages
2.ADVERSE EVE
NT 2 Chills Jan/6/2021 21:00 NO
End Date Time:
Jan/7/2021 UNK:UNK
Repeating
Pages
3.ADVERSE EVE
NT 3 Fever Jan/6/2021 UNK:U
NK NO
End Date Time:
Jan/7/2021 UNK:UNK
Repeating
Pages
4.ADVERSE EVE
NT 4 Adenopathy (left arm
pit) Feb/8/2021 UNK:U
NK YES Repeating
Pages
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925902
Page 37 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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)[Headache]
4.Start Date Time: Jan/7/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925903
Page 38 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Chills]
4.Start Date Time: Jan/6/2021 21:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/7/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925904
Page 39 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925905
Page 40 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fever]
4.Start Date Time: Jan/6/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/7/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925906
Page 41 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925907
Page 42 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Adenopathy (left armpit)]
4.Start Date Time: Feb/8/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925908
Page 43 of 203
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Acti
onForm Instance
1. Repeating Pages
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925909
Page 44 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925910
Page 45 of 203
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre-
specifiedName of Medicatio
nStart Dat
eForm Instanc
e
1.1 VACCINATIONS NO Quadrivalent Flu Va
ccine Sep/14/20
20 Repeating
Pages
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925911
Page 46 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Quadrivalent Flu Vaccine]
5.Date: Sep/14/2020
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925912
Page 47 of 203
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre-
specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925913
Page 48 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925914
Page 49 of 203
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925915
Page 50 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925916
Page 51 of 203
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925917
Page 52 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925918
Page 53 of 203
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925919
Page 54 of 203
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925920
Page 55 of 203
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925921
Page 56 of 203
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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:
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925922
Page 57 of 203
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925923
Page 58 of 203
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925924
Page 59 of 203
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925925
Page 60 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925926
Page 61 of 203
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925927
Page 62 of 203
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925928
Page 63 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925929
Page 64 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/18/2020
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925930
Page 65 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925931
Page 66 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Dec/18/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925932
Page 67 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/18/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925933
Page 68 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/18/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW5JR]
5.bSample ID [BNPZ0W]
5.cSample ID [BNPZ0V]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925934
Page 69 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/18/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW5HN]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925935
Page 70 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Dec/18/2020 09:09
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925936
Page 71 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/16/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925937
Page 72 of 203
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925938
Page 73 of 203
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925939
Page 74 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925940
Page 75 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/6/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925941
Page 76 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/6/2021
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN4Z6Z]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925942
Page 77 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/6/2021 09:11
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925943
Page 78 of 203
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925944
Page 79 of 203
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/4/2021
3.Comments: [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925945
Page 80 of 203
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925946
Page 81 of 203
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925947
Page 82 of 203
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925948
Page 83 of 203
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925949
Page 84 of 203
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Feb/4/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925950
Page 85 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/19/2020
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925951
Page 86 of 203
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925952
Page 87 of 203
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jeffrey Rosen Approved Mar-01-2021 18:09:41 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, 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.
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0925953
Page 88 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormSep-17-2020 15:00:10 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925954
Page 89 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormSep-22-2020 10:14:29 (UTC-05:00) Eastern Time
(US & Canada)subject was not randomized. temporary Delay
Criteria. Subject will come back on 29-Sep-2020
FormSep-17-2020 15:18:44 (UTC-05:00) Eastern Time
(US & Canada)
FormSep-17-2020 15:17:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925955
Page 90 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Sep-22-2020 10:14:19 (UTC-05:00) Eastern Time
(US & Canada)subject was not randomized. temporary Delay
Criteria. Subject will come back on 29-Sep-2020
1Sep-17-2020 15:18:44 (UTC-05:00) Eastern Time
(US & Canada)
1Sep-17-2020 15:17:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925956
Page 91 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Sep-17-2020 15:18:44 (UTC-05:00) Eastern Time
(US & Canada)
2Sep-17-2020 15:17:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925957
Page 92 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Sep-17-2020 15:18:44 (UTC-05:00) Eastern Time
(US & Canada)
3Sep-17-2020 15:17:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925958
Page 93 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Sep-17-2020 15:18:44 (UTC-05:00) Eastern Time
(US & Canada)
4Sep-17-2020 15:17:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925959
Page 94 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Sep-17-2020 15:18:44 (UTC-05:00) Eastern Time
(US & Canada)
5Sep-17-2020 15:17:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925960
Page 95 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6Sep-17-2020 15:18:44 (UTC-05:00) Eastern Time
(US & Canada)
6Sep-17-2020 15:17:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925961
Page 96 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
7.aSep-17-2020 15:18:44 (UTC-05:00) Eastern Time
(US & Canada)
7.aSep-17-2020 15:17:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925962
Page 97 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
7.aSep-17-2020 15:18:44 (UTC-05:00) Eastern Time
(US & Canada)
7.aSep-17-2020 15:17:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925963
Page 98 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
7.aSep-17-2020 15:18:44 (UTC-05:00) Eastern Time
(US & Canada)
7.aSep-17-2020 15:17:02 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925964
Page 99 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormSep-17-2020 15:17:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925965
Page 100 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Sep-17-2020 15:17:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925966
Page 101 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Sep-17-2020 15:17:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925967
Page 102 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Sep-17-2020 15:17:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925968
Page 103 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Sep-17-2020 15:17:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925969
Page 104 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Sep-17-2020 15:17:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925970
Page 105 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aSep-17-2020 15:17:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925971
Page 106 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aSep-17-2020 15:17:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925972
Page 107 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6.aSep-17-2020 15:17:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925973
Page 108 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormSep-17-2020 15:18:06 (UTC-05:00) Eastern Time
(US & Canada)
FormSep-17-2020 15:17:53 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925974
Page 109 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Sep-22-2020 10:13:05 (UTC-05:00) Eastern Time
(US & Canada)subject was not randomized. temporary Delay
Criteria. Subject will come back on 29-Sep-2020
1Sep-17-2020 15:18:06 (UTC-05:00) Eastern Time
(US & Canada)
1Sep-17-2020 15:17:53 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925975
Page 110 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Sep-22-2020 10:13:18 (UTC-05:00) Eastern Time
(US & Canada)subject was not randomized. temporary Delay
Criteria. Subject will come back on 29-Sep-2020
2Sep-17-2020 15:18:06 (UTC-05:00) Eastern Time
(US & Canada)
2Sep-17-2020 15:17:53 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925976
Page 111 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Sep-17-2020 15:18:06 (UTC-05:00) Eastern Time
(US & Canada)
3Sep-17-2020 15:17:53 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925977
Page 112 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Sep-22-2020 10:13:33 (UTC-05:00) Eastern Time
(US & Canada)subject was not randomized. temporary Delay
Criteria. Subject will come back on 29-Sep-2020
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925978
Page 113 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6Sep-22-2020 10:13:44 (UTC-05:00) Eastern Time
(US & Canada)subject was not randomized. temporary Delay
Criteria. Subject will come back on 29-Sep-2020
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925979
Page 114 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
11Sep-22-2020 10:13:56 (UTC-05:00) Eastern Time
(US & Canada)subject was not randomized. temporary Delay
Criteria. Subject will come back on 29-Sep-2020
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925980
Page 115 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormDec-18-2020 17:08:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0925981
Page 116 of 203
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jeffrey Rosen Approved Mar-01-2021 18:09:41 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is
to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-25-2021 19:19:53 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Rosen Approved Feb-11-2021 20:04:24 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is
to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-09-2021 18:09:15 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Rosen Approved Feb-09-2021 12:17:41 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925982
Page 117 of 203
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Affidavit:
By my dated signature below, I, JeffreyRosen, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is
to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-08-2021 10:57:12 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Rosen Approved Feb-05-2021 18:46:24 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is
to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-04-2021 12:15:28 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Rosen Approved Jan-21-2021 13:06:48 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is
to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-17-2020 11:02:58 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925983
Page 118 of 203
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Affidavit:
N/A
Jeffrey Rosen Approved Dec-10-2020 17:20:27 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is
to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-19-2020 12:55:08 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Rosen Approved Nov-10-2020 14:34:32 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, 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.
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0925984
Page 119 of 203
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-17-2020 14:55:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-17-2020 14:55:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0925985
Page 120 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-17-2020 14:57:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/17/2020Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0925986
Page 121 of 203
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-17-2020 14:55:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11101271Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-17-2020 14:55:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1977Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-17-2020 14:58:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-17-2020 14:58:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-17-2020 14:58:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0925987
Page 122 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020 08:47:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query.
Oct-06-2020 07:50:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered done
Sep-30-2020 06:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Form is unfrozen.
Please consider to
update the data as
appropriate. Thank
you.
Sep-29-2020 18:34:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered please unfreeze
pregnancy page to
update with negative
results as a urine test
was performed at
delayed visit.
Sep-29-2020 06:54:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Thank you for
confirming. Please
respond to query only
once updates are made.
Sep-28-2020 11:13:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered This is a temporary
delay visit. Subject is
scheduled to return 29
SEP 2020 to complete
visit 1.
Sep-28-2020 02:51:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly review and
complete
‘Immunogenicity,
Nasal Swab forms' at
this visit. Thank you.
Sep-17-2020 15:00:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0925988
Page 123 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-17-2020 15:00:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-17-2020 15:00:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-17-2020 15:00:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0925989
Page 124 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.a
Date Location User Value Reason
Sep-17-2020 15:01:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:appendicitis
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/20
08Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-17-2020 15:01:40
(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
Sep-17-2020 15:01:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
appendicitisInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-17-2020 15:01:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-17-2020 15:01:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
1.b
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0925990
Page 125 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Sep-17-2020 15:03:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:appendectomy
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/20
08Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-17-2020 15:03:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 15:03:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
appendectomyInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-17-2020 15:03:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-17-2020 15:03:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
1.c
Date Location User Value Reason
Sep-17-2020 15:03:56
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0925991
Page 126 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada) Medical History Term
:cesarean sectio
n
Start Date: Jul/7/2010
Ongoing: NO
End Date:
Jul/7/2010
1.c Line/MH Number:
Date Location User Value Reason
Sep-17-2020 15:03:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 15:03:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cesarean sectionInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-17-2020 15:03:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/7/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-17-2020 15:03:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jul/7/2010Initial Entry
1.d
Date Location User Value Reason
Sep-17-2020 15:05:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Term
:cesarean sectio
n
Start Date: Nov/9/2018Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0925992
Page 127 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Ongoing: NO
End Date:
Nov/9/2018
1.d Line/MH Number:
Date Location User Value Reason
Sep-17-2020 15:05:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 15:05:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cesarean sectionInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-17-2020 15:05:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/9/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-17-2020 15:05:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Nov/9/2018Initial Entry
1.e
Date Location User Value Reason
Sep-17-2020 15:06:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:bilateral salpingect
omy
Start Date: Nov/9/2018
Ongoing: NO
End Date:
Nov/9/2018Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0925993
Page 128 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.e Line/MH Number:
Date Location User Value Reason
Sep-17-2020 15:06:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 15:06:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
bilateral salpingectomyInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-17-2020 15:06:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/9/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-17-2020 15:06:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Nov/9/2018Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0925994
Page 129 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-17-2020 15:07:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be HIV
POSITIVEInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0925995
Page 130 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Sep-30-2020 06:43:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-29-2020 18:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered This was a delayed
criteria visit and vitals
were completed on day
of randomization and
vaccination.
Sep-29-2020 18:35:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Vital signs Date
29/Sep/2020 is not
same as Date of Visit
17/Sep/2020. Please
review and update as
appropriate or clarify.
Sep-29-2020 18:35:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/29/2020Initial Entry
Sep-17-2020 15:18:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-17-2020 15:17:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Weight:
Date Location User Value Reason
Sep-29-2020 18:35:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
61.7Initial Entry
Sep-17-2020 15:18:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-17-2020 15:17:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Unit:
Date Location User Value Reason
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0925996
Page 131 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-29-2020 18:35:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
Sep-17-2020 15:18:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-17-2020 15:17:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Height:
Date Location User Value Reason
Sep-29-2020 18:35:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
165.0Initial Entry
Sep-17-2020 15:18:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-17-2020 15:17:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Unit:
Date Location User Value Reason
Sep-29-2020 18:35:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
Sep-17-2020 15:18:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-17-2020 15:17:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-29-2020 18:35:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.7Initial Entry
Sep-17-2020 15:18:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0925997
Page 132 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-17-2020 15:17:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7.a
Date Location User Value Reason
Sep-29-2020 18:35:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: Not Done
Temperature: 36.2
Temperature Unit: C
Temperature Location
::FOREHEA
DInitial Entry
Sep-17-2020 15:18:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: Not Done
Temperature:
Temperature Unit:
Temperature Location::Initial Entry
Sep-17-2020 15:17:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: Not Done
Temperature: Not Done
Temperature Unit: Not Done
Temperature Location:: Not DoneInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-17-2020 15:17:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7.a Temperature:
Date Location User Value Reason
Sep-29-2020 18:35:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.2Initial Entry
Sep-17-2020 15:18:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-17-2020 15:17:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0925998
Page 133 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7.a Unit:
Date Location User Value Reason
Sep-29-2020 18:35:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
Sep-17-2020 15:18:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-17-2020 15:17:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-29-2020 18:35:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
Sep-17-2020 15:18:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-17-2020 15:17:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0925999
Page 134 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-17-2020 15:17:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-17-2020 15:17:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-17-2020 15:17:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-17-2020 15:17:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-17-2020 15:17:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-17-2020 15:17:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defined Ident
ifier:Not Applica
ble
Test:: Not Applica
ble
Result:: Not Applica
bleInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926000
Page 135 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Not Done:: Not Applica
ble
6.a Sponsor ID:
Date Location User Value Reason
Sep-17-2020 15:17:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep 17 2020 15 17 24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-17-2020 15:17:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-17-2020 15:17:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926001
Page 136 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-30-2020 06:42:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-29-2020 18:38:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered this was a delayed
criteria visit and
randomization visit
was on the date
captured.
Sep-29-2020 18:37:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Randomization Date
29/Sep/2020 is before
or more than 1 day
after corresponding
Date of Visit 17/Sep
/2020. Please review
and update as
appropriate.
Sep-29-2020 18:37:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/29/2020Initial Entry
Sep-17-2020 15:18:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-17-2020 15:17:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-30-2020 06:42:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-29-2020 18:37:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Sep-29-2020 18:37:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
101399Initial Entry
Sep-25-2020 07:54:09
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Query 1: Reissued:Opened DM: Thank you for
your response.
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926002
Page 137 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada) However, please keep
the query open until
updates are made. Else
clarify.
Sep-24-2020 09:38:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Will do.
Sep-23-2020 07:23:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM2: Thank you for
confirming. Please
respond to this query
once action has been
taken.
Sep-22-2020 10:12:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered subject was not
randomized. temporary
Delay Criteria. Subject
will come back on
29-Sep-2020
Sep-22-2020 06:06:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Thank you for
confirming. Please
respond to this query
once action has been
taken.
Sep-21-2020 16:11:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Number is not
incomplete as per
vaccination page
subject is delayed. No
randomization number
assigned yet.
Sep-21-2020 07:39:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Randomization
Number is incomplete.
Please provide the
data.
Sep-17-2020 15:18:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-17-2020 15:17:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Randomization Group:
Date Location User Value Reason
Sep-17-2020 15:18:06
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926003
Page 138 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada)
Sep-17-2020 15:17:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926004
Page 139 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 18:39:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 18:39:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020
08:33:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Close
dResponse satisfies
query.
Oct-06-2020
07:49:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answ
eredThis was a delay
vaccination for that
reason the date of
sample collection is
different
Sep-29-2020
21:20:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2: Open
edDMW4849422;Date
of Collection is
earlier or more than 1
day after Date of
Visit. Please clarify
or correct.
Sep-29-2020
18:40:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Delet
edClose Auto Query
Sep-29-2020
18:39:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candi
date'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0926005
Page 140 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-29-2020
18:39:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Colle
ction:
Sep/29/2020Initial Entry
5.a
Date Location User Value Reason
Sep-29-2020 18:40:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY0C9Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020 18:40:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPY0C9Initial Entry
5.b
Date Location User Value Reason
Sep-29-2020 18:40:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRVHS3Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-29-2020 18:40:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BRVHS3Initial Entry
5.c
Date Location User Value Reason
Sep-29-2020 18:40:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRVHS4Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926006
Page 141 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.c Sample ID
Date Location User Value Reason
Sep-29-2020 18:40:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BRVHS4Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926007
Page 142 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 18:41:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 18:41:05
(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-30-2020 06:41:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Vaccination delay
confirmed and
updated.
Sep-29-2020 18:41:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Sep-29-2020 18:41:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Sep-29-2020 18:41:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-29-2020 18:41:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of Collection
29/Sep/2020 is more
than 1 day after Date
of Visit 17/Sep/2020.
Please review and
update as appropriate,
else clarify.
Sep-29-2020 18:41:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/29/2020Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926008
Page 143 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.a
Date Location User Value Reason
Sep-29-2020 18:41:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY0GZInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020 18:41:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPY0GZInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926009
Page 144 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-11-2020 20:55:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-06-2020 07:48:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Update
Oct-01-2020 20:24:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Vax1
delayed due to recent
non-study vaccination
but no record on
concomitant
medications - non
study vaccinations
CRF. Please and
update as appropriate,
or otherwise clarify.
Sep-17-2020 15:19:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of First Delay:
Sep/17/2020
Reason(s) for Temporary Delay of V
accination
RECENT NON-STUDY VACCIN
ATIONInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-29-2020 18:39:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-29-2020 18:39:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926010
Page 145 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
4. Dose Date Time:
Date Location User Value Reason
Sep-30-2020 06:41:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Vaccination delay
confirmed and
updated.
Sep-29-2020 18:39:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Sep-29-2020 18:39:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Dose Date is before or
more than 1 day after
Date of Visit
17/Sep/2020 of the
corresponding Visit.
Please review and
update as appropriate.
Sep-29-2020 18:39:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/29/2020 10:12Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-29-2020 18:39:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-29-2020 18:39:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-29-2020 18:39:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-29-2020 18:39:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSER
VATION PERIODInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926011
Page 146 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-29-2020 18:39:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926012
Page 147 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-17-2020 15:19:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926013
Page 148 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020 21:55:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926014
Page 149 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Oct-20-2020 22:05:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
2.a
Date Location User Value Reason
Oct-20-2020 22:05:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.3
Temperature Unit: C
Temperature Location
::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-20-2020 22:05:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-20-2020 22:05:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.3Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-20-2020 22:05:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-20-2020 22:05:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926015
Page 150 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-20-2020 22:05:32
(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-20-2020 22:05:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-20-2020 22:05:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-20-2020 22:05:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-20-2020 22:05:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-20-2020 22:05:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926016
Page 151 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
6.a Sponsor ID:
Date Location User Value Reason
Oct-20-2020 22:05:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-20-2020 22:05:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-20-2020 22:05:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926017
Page 152 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 22:05:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 22:05:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 22:06:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-20-2020 22:05:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-20-2020 22:05:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020 22:06:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW9CBInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 22:06:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPW9CBInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926018
Page 153 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-20-2020 22:06:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-20-2020 22:06:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-20-2020 22:06:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-20-2020 22:06:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020 09:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-20-2020 22:06:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-20-2020 22:06:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926019
Page 154 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Oct-20-2020 22:06:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-20-2020 22:06:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSER
VATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-20-2020 22:06:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926020
Page 155 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-19-2020 12:55:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/19/2020Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926021
Page 156 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-19-2020 12:55:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-19-2020 12:55:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-19-2020 13:02:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-19-2020 12:55:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-19-2020 12:55:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/19/2020Initial Entry
5.a
Date Location User Value Reason
Nov-19-2020 13:02:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW5BLInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-19-2020 13:02:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPW5BLInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926022
Page 157 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.b
Date Location User Value Reason
Nov-19-2020 13:07:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRVHX4Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-19-2020 13:07:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BRVHX4Initial Entry
5.c
Date Location User Value Reason
Nov-19-2020 13:14:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRVHX5Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-19-2020 13:14:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BRVHX5Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926023
Page 158 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Jan-07-2021 09:16:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926024
Page 159 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Jan-07-2021 09:17:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926025
Page 160 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Jan-07-2021 09:18:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926026
Page 161 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Feb-09-2021 18:09:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926027
Page 162 of 203
***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
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Jan-07-2021 09:16:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-07-2021 09:16:07
(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
Jan-07-2021 09:16:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HeadacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-07-2021 09:16:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/7/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-07-2021 09:16:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-07-2021 09:16:07
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926028
Page 163 of 203
***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
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-07-2021 09:16:07
(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
Jan-07-2021 09:16:07
(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
Jan-07-2021 09:16:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-07-2021 09:16:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926029
Page 164 of 203
***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
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Jan-07-2021 09:16:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-07-2021 09:16:07
(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
Jan-07-2021 09:18:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-07-2021 09:16:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926030
Page 165 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Jan-07-2021 09:17:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-07-2021 09:17:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-07-2021 09:17:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ChillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-07-2021 09:17:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021 21:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-07-2021 09:17:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/7/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926031
Page 166 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Jan-07-2021 09:17:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-07-2021 09:17:13
(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
Jan-07-2021 09:17:13
(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
Jan-07-2021 09:17:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-07-2021 09:17:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926032
Page 167 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-07-2021 09:17:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-07-2021 09:17:13
(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
Jan-07-2021 09:17:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-07-2021 09:17:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926033
Page 168 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Jan-07-2021 09:18:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-07-2021 09:18:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-07-2021 09:18:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FeverInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-07-2021 09:18:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-07-2021 09:18:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/7/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926034
Page 169 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Jan-07-2021 09:18:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-07-2021 09:18:04
(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
Jan-07-2021 09:18:04
(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
Jan-07-2021 09:18:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-07-2021 09:18:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926035
Page 170 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-07-2021 09:18:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-07-2021 09:18:04
(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
Jan-07-2021 09:18:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-07-2021 09:18:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926036
Page 171 of 203
***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
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Feb-09-2021 18:09:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-09-2021 18:09:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-09-2021 18:09:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Adenopathy (left armpit)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-09-2021 18:09:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/8/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-09-2021 18:09:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926037
Page 172 of 203
***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
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Feb-09-2021 18:09:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-09-2021 18:09:15
(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
Feb-09-2021 18:09:15
(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
Feb-09-2021 18:09:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-09-2021 18:09:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926038
Page 173 of 203
***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
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-09-2021 18:09:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-09-2021 18:09:15
(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
Feb-09-2021 18:09:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-09-2021 18:09:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926039
Page 174 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Oct-06-2020 07:48:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926040
Page 175 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-06-2020 07:48:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Oct-06-2020 07:48:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-06-2020 07:48:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter the full
trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Oct-06-2020 07:48:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Quadrivalent Flu VaccineInitial Entry
5. Date:
Date Location User Value Reason
Oct-06-2020 07:48:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926041
Page 176 of 203
***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, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-19-2020 13:19:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-19-2020 13:19:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-19-2020 13:19:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926042
Page 177 of 203
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021 19:19:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/16/2020Transcription Error
Dec-18-2020 17:07:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926043
Page 178 of 203
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-18-2020 17:07:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for Vacci
nation 3
Participant is:
eligible per local/national recommen
dations and confirmed to have receiv
ed only placebo at Vaccination 1/2Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926044
Page 179 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-18-2020 17:07:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926045
Page 180 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-18-2020 17:07:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/18/2020Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926046
Page 181 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-18-2020 17:10:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-18-2020 17:10:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-18-2020 17:10:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926047
Page 182 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-18-2020 17:10:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-18-2020 17:10:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-18-2020 17:10:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-18-2020 17:10:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-18-2020 17:10:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Dec-18-2020 17:10:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926048
Page 183 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
6.a Sponsor ID:
Date Location User Value Reason
Dec-18-2020 17:10:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-18-2020 17:10:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Dec-18-2020 17:10:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926049
Page 184 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020 17:10:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020 17:10:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-18-2020 17:11:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 17:10:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-18-2020 17:10:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/18/2020Initial Entry
5.a
Date Location User Value Reason
Dec-18-2020 17:11:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW5JRInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-18-2020 17:11:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPW5JRInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926050
Page 185 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.b
Date Location User Value Reason
Dec-18-2020 17:11:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNPZ0WInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-18-2020 17:11:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNPZ0WInitial Entry
5.c
Date Location User Value Reason
Dec-18-2020 17:12:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNPZ0VInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-18-2020 17:12:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNPZ0VInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926051
Page 186 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020 17:12:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020 17:12:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-18-2020 17:12:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 17:12:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-18-2020 17:12:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/18/2020Initial Entry
5.a
Date Location User Value Reason
Dec-18-2020 17:12:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW5HNInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-18-2020 17:12:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPW5HNInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926052
Page 187 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-18-2020 17:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-18-2020 17:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-18-2020 17:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-18-2020 17:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020 09:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-18-2020 17:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-18-2020 17:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926053
Page 188 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Dec-18-2020 17:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-18-2020 17:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-18-2020 17:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-18-2020 17:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Dec-18-2020 17:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926054
Page 189 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-26-2021
05:50:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Clos
edSite has updated the
data per query.
Feb-25-2021
17:43:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Ans
weredplease unfreeze revax
contact page to answer
the query.
Feb-24-2021
06:21:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reis
sued:OpenedDM RQ1: Thank you
for the response,
however Unblinding
cannot be before
REVAX date. Please
discuss with CRA and
update correct data as
appropriate or else
clarify. Thank you.
Feb-23-2021
11:21:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Ans
weredDate Treatment
Unblinded is prior to
the Date of Visit for the
Revax Contact Visit
when “Assess
Eligibility for
Additional
Vaccination” is selected
on the Treatment
Unblinded form as per
sponsor.
Feb-23-2021
03:16:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: Ope
nedDMW7351498;Date
Treatment Unblinded
should be equal to or
after DOV in REVAX
CONTACT visit when
Reason is ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION.Please
review and update as
appropriate.
Dec-17-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0926055
Page 190 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11:02:58
(UTC-05:00)
Eastern Time
(US & Canada)Dec/16/2020
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-17-2020 11:02:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR ADDITI
ONAL VACCINATIONInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926056
Page 191 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-06-2021 16:45:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926057
Page 192 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-06-2021 16:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-06-2021 16:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-06-2021 16:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-06-2021 16:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-06-2021 16:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jan-06-2021 16:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926058
Page 193 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
6.a Sponsor ID:
Date Location User Value Reason
Jan-06-2021 16:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-06-2021 16:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Jan-06-2021 16:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926059
Page 194 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-06-2021 16:47:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-06-2021 16:47:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-06-2021 16:51:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-06-2021 16:47:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-06-2021 16:47:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/6/2021Initial Entry
5.a
Date Location User Value Reason
Jan-06-2021 16:51:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN4Z6ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-06-2021 16:51:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN4Z6ZInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926060
Page 195 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-06-2021 16:51:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-06-2021 16:51:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-06-2021 16:51:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-06-2021 16:51:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021 09:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-06-2021 16:51:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-06-2021 16:51:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926061
Page 196 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Jan-06-2021 16:51:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-06-2021 16:51:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-06-2021 16:51:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-06-2021 16:51:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Jan-06-2021 16:51:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926062
Page 197 of 203
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021 12:15:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2021Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926063
Page 198 of 203
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-04-2021 12:15:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-04-2021 12:15:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Feb/4/2021Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0926064
Page 199 of 203
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User ValueReason
Feb-10-2021
02:35:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
4: Clo
sedIncorrect query
Feb-09-2021
23:13:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
4: Op
enedDMW7213954;Status on the
Disposition - Treatment form is
COMPLETED, but Date is
different than Visit 3 Date. Please
review and update as appropriate.
Feb-09-2021
22:06:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Clo
sedAuto closed by Validation Check:
VC_DS001_30
Feb-09-2021
18:10:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Ans
weredTranscription Error
Feb-09-2021
18:10:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Feb/4/
2021Transcription Error
Feb-09-2021
03:55:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Clo
sedIncorrect query
Feb-08-2021
16:23:45
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
3: Op
enedDMW7189062;Status on the
Disposition - Treatment form is
COMPLETED, but Date is
different than Visit 3 Date. Please
review and update as appropriate.
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0926065
Page 200 of 203
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Canada)
Feb-08-2021
15:45:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Rei
ssued:
Opene
dReopen: Status on the Disposition
- Treatment form is COMPLETED
at
FURTHER_VACCINATION_EOT
visit, but Date is different than
Visit V103 Date. Please review
and update as appropriate.
Feb-08-2021
10:57:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Ans
weredTranscription Error
Feb-08-2021
10:57:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Jan/4/
2021Transcription Error
Feb-08-2021
04:29:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Balaji Prabu R Query
1: Clo
sedIncorrect query
Feb-04-2021
22:16:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Op
enedDMW7158035;Status on the
Disposition - Treatment form is
COMPLETED at
FURTHER_VACCINATION_EOT
visit, but Date is different than
Visit V103 Date. Please review
and update as appropriate.
Feb-04-2021
21:59:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7157962;Status on the
Disposition - Treatment form is
COMPLETED, but Date is
different than Visit 3 Date. Please
review and update as appropriate.
Feb-04-2021
13:12:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Jan/6/
2021Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0926066
Page 201 of 203
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2. Phase of Disposition:
Date Location User Value Reason
Feb-04-2021 13:12:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Feb-08-2021 10:57:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
Feb-08-2021 10:57:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Feb-04-2021 13:12:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0926067
Page 202 of 203
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-19-2020 13:19:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-29-2020 18:37:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-17-2020 15:00:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-19-2020 13:19:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/19/2020Initial Entry
Sep-29-2020 18:37:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/29/2020Initial Entry
Sep-17-2020 15:00:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/17/2020Initial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0926068
Page 203 of 203
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101271 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-17-2020 16:34:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3d9f\Final\Final On: 01-Apr-2021 04:39 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0926069