Document text
Page 1 of 156
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797811
Page 2 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/18/2020
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797812
Page 3 of 156
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11181057]
2.Birth Date: /1957
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797813
Page 4 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/18/2020
2.Erroneous Visit
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797814
Page 5 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797815
Page 6 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797816
Page 7 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[migraines]
Start Date: UNK/UNK/1977
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[post menopausal]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2009
Ongoing: YES
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797817
Page 8 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypothyroidism]
Start Date: UNK/UNK/2009
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[metamucil allergy]
Start Date: UNK/UNK/1990
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[dermatitis]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797818
Page 9 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Aug/18/2020
2.Weight: [52.9]
3.Unit: kg
4.Height: [162.3]
5.Unit: cm
6.Body Mass Index: [20.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797819
Page 10 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/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:
Not Done: NOT DONE
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797820
Page 11 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/18/2020
2.Randomization Number: [232270]
3.Randomization Group: [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797821
Page 12 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/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 [BP50JY]
5.bSample ID [BP50K0]
5.cSample ID [BP50JZ]
5.dSample ID [BPR7XW]
5.eSample ID [BPR7XX]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797822
Page 13 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/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 [BP50LD]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797823
Page 14 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/18/2020 15:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797824
Page 15 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797825
Page 16 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797826
Page 17 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797827
Page 18 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/10/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797828
Page 19 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BP50S9]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797829
Page 20 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/10/2020 12:18
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797830
Page 21 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797831
Page 22 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
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 [BP511B]
5.bSample ID [BPR85H]
5.cSample ID [BPR857]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797832
Page 23 of 156
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/4/2021
2.Erroneous Visit
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797833
Page 24 of 156
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/4/2021
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 [BRTCFF]
5.bSample ID [BP5WPD]
5.cSample ID [BPNWM5]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797834
Page 25 of 156
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797835
Page 26 of 156
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797836
Page 27 of 156
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797837
Page 28 of 156
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797838
Page 29 of 156
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797839
Page 30 of 156
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797840
Page 31 of 156
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797841
Page 32 of 156
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797842
Page 33 of 156
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797843
Page 34 of 156
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797844
Page 35 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797845
Page 36 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797846
Page 37 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797847
Page 38 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Unplanned Assessments
1.Assessments
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797848
Page 39 of 156
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/8/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797849
Page 40 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797850
Page 41 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797851
Page 42 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797852
Page 43 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Iden
tifierAdverse Eve
ntStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Sigmoid dive
rticulitis Sep/4/2020 U
NK:UNK NO
End Date Time:
Sep/18/2020 00:00
Repeating
Pages
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797853
Page 44 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
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)[Sigmoid diverticulitis]
4.Start Date Time: Sep/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/18/2020 00:00
6.Toxicity Grade: 3
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797854
Page 45 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Sigmoid diverticulosis]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797855
Page 46 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[2020357707]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797856
Page 47 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication Er
rors ActionForm Instanc
e
1. Repeating
Pages
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797857
Page 48 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797858
Page 49 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicat
ions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797859
Page 50 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt
form, where applicable).
Where generic name is
unknown, enter the full trade
or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797860
Page 51 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797861
Page 52 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797862
Page 53 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Catego
ryTreatment Iden
tifierCon Non-Drug Treatments Pr
e-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797863
Page 54 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797864
Page 55 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797865
Page 56 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797866
Page 57 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797867
Page 58 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797868
Page 59 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797869
Page 60 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797870
Page 61 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797871
Page 62 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797872
Page 63 of 156
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797873
Page 64 of 156
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797874
Page 65 of 156
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797875
Page 66 of 156
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797876
Page 67 of 156
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797877
Page 68 of 156
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response -
Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797878
Page 69 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797879
Page 70 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Withdrawal Of Consent
1.Withdrawal of Consent Date
://
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797880
Page 71 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797881
Page 72 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/8/2020
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797882
Page 73 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797883
Page 74 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797884
Page 75 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormAug-19-2020 07:17:02 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797885
Page 76 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormSep-25-2020 11:03:47 (UTC-05:00)
Eastern Time (US & Canada)REACHED OUT TO SUBJECT AND
LEFT MESSAGE REGARDING THE
STATUS OF SIGMOID
DIVERTICULITIS SAE. SIGHT
WILL FOLLOW UP TO
DETERMINE IF CONDITION IS
STILL ONGOING OR IF IT HAS
BEEN RESOLVED.
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797886
Page 77 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-04-2021 14:01:55 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-09-2021 08:39:03 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Jan-26-2021 16:44:16 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797887
Page 78 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Approved Oct-12-2020 12:48:51 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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 Sep-25-2020 11:03:47 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Sep-17-2020 11:53:51 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, 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.
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797888
Page 79 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
N/A Sep-16-2020 07:06:31 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Sep-14-2020 14:45:23 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797889
Page 80 of 156
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-19-2020
07:16:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-19-2020
07:16:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797890
Page 81 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-19-2020
07:16:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent O
btained
Aug/18/2020Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797891
Page 82 of 156
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-19-2020
07:16:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11181057Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-19-2020
07:16:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1957Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-19-2020
07:16:39
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-19-2020
07:16:39ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LAInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797892
Page 83 of 156
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US &
Canada)TINO(A) OR OF SPANI
SH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-19-2020
07:16:39
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0797893
Page 84 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-19-2020
07:16:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797894
Page 85 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-19-2020
07:17:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-19-2020
07:17:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-19-2020
07:17:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797895
Page 86 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Aug-19-2020
07:18:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:migraines
Start Date: UNK/UN
K/1977
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-19-2020
07:18:03
(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
Aug-19-2020
07:18:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
migrainesInitial Entry
1.a Start Date:
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797896
Page 87 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-19-2020
07:18:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1977Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-19-2020
07:18:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-19-2020
07:18:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:post men
opausal
Start Date: UNK/UN
K/2015
Ongoing: YESInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797897
Page 88 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Line/MH Number:
Date Location User Value Reason
Aug-19-2020
07:18:20
(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
Aug-19-2020
07:18:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
post menopausalInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-19-2020
07:18:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-19-2020
07:18:20
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797898
Page 89 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Canada)
1.c
Date Location User Value Reason
Aug-19-2020
07:18:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:hypertens
ion
Start Date: UNK/UN
K/2009
Ongoing: YESInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797899
Page 90 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.c Line/MH Number:
Date Location User Value Reason
Aug-19-2020
07:18:38
(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
Aug-19-2020
07:18:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
hypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-19-2020
07:18:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-19-2020
07:18:38
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797900
Page 91 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Canada)
1.d
Date Location User Value Reason
Aug-19-2020
07:18:57
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:hypothyr
oidism
Start Date: UNK/UN
K/2009
Ongoing: YESInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797901
Page 92 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.d Line/MH Number:
Date Location User Value Reason
Aug-19-2020
07:18:57
(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
Aug-19-2020
07:18:57
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
hypothyroidismInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-19-2020
07:18:57
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-19-2020
07:18:57
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797902
Page 93 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Canada)
1.e
Date Location User Value Reason
Aug-19-2020
07:19:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Hist
ory Term:metamuci
l allergy
Start Date: UNK/UN
K/1990
Ongoing: YESInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797903
Page 94 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.e Line/MH Number:
Date Location User Value Reason
Aug-19-2020
07:19:25
(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
Aug-19-2020
07:19:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
metamucil allergyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-19-2020
07:19:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-19-2020
07:19:25
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797904
Page 95 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Canada)
1.f
Date Location User Value Reason
Aug-19-2020
07:19:42
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:dermatitis
Start Date: UNK/UN
K/1990
Ongoing: YESInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797905
Page 96 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.f Line/MH Number:
Date Location User Value Reason
Aug-19-2020
07:19:42
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020
07:19:42
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
dermatitisInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-19-2020
07:19:42
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-19-2020
07:19:42
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797906
Page 97 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Canada)
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797907
Page 98 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Aug-19-2020
07:19:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-19-2020
07:20:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
52.9Initial Entry
3. Unit:
Date Location User Value Reason
Aug-19-2020
07:20:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797908
Page 99 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-19-2020
07:20:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
162.3Initial Entry
5. Unit:
Date Location User Value Reason
Aug-19-2020
07:20:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-19-2020
07:20:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
20.1Initial Entry
7.a
Date Location User Value Reason
Aug-19-2020
07:20:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Record Ident
ifier::1
Temperature
:36.8
Temperature
Unit:CInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797909
Page 100 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Temperature
Location::ORAL C
AVITY
Aug-19-2020
07:19:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature:
Temperature Unit:
Temperature Locatio
n::Initial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-19-2020
07:19:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-19-2020
07:20:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-19-2020
07:20:20ACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797910
Page 101 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US &
Canada)
7.a Temperature Location:
Date Location User Value Reason
Aug-19-2020
07:20:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0797911
Page 102 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-19-2020
07:20:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-19-2020
07:20:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-19-2020
07:20:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797912
Page 103 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-19-2020
07:20:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-19-2020
07:20:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-19-2020
07:20:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-D
efined Ide
ntifier:113
Test:: Choriogona
dotropin Bet
a_PX113
Result::
Not Done:
:NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-19-2020 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797913
Page 104 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
07:20:51
(UTC-05:00)
Eastern Time (US &
Canada)(autocalc) 113
6.a Test:
Date Location User Value Reason
Aug-19-2020
07:20:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta
_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-19-2020
07:20:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797914
Page 105 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-19-2020
07:21:13
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-19-2020
07:21:13
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
232270Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797915
Page 106 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020
07:21:39
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020
07:21:39
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020
07:21:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-19-2020
07:21:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797916
Page 107 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
review and
correct as
appropriate.
Aug-19-2020
07:21:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020
07:21:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP50JYInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-19-2020
07:21:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BP50JYInitial Entry
5.b
Date Location User Value Reason
Aug-19-2020
07:22:06
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Sample ID: BP50K0Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797917
Page 108 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US &
Canada)
5.b Sample ID
Date Location User Value Reason
Aug-19-2020
07:22:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BP50K0Initial Entry
5.c
Date Location User Value Reason
Aug-19-2020
07:22:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP50JZInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-19-2020
07:22:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BP50JZInitial Entry
5.d
Date Location User Value Reason
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797918
Page 109 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-19-2020
07:22:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR7XWInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-19-2020
07:22:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BPR7XWInitial Entry
5.e
Date Location User Value Reason
Aug-19-2020
07:22:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR7XXInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-19-2020
07:22:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BPR7XXInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797919
Page 110 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020
07:23:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020
07:23:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020
07:23:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-19-2020
07:23:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797920
Page 111 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
review and
correct as
appropriate.
Aug-19-2020
07:23:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020
07:23:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP50LDInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-19-2020
07:23:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BP50LDInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797921
Page 112 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-19-2020
07:24:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-19-2020
07:24:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-19-2020
07:24:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-19-2020
07:24:09ACV0PFEINFP6000 Data Entry:
Aug/18/2020 15:32Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797922
Page 113 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US &
Canada)
5. Anatomical Location:
Date Location User Value Reason
Aug-19-2020
07:24:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-19-2020
07:24:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-19-2020
07:24:09
(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
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0797923
Page 114 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-19-2020
07:24:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEC
IFIED OBSERVATION
PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-19-2020
07:24:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797924
Page 115 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-19-2020
12:28:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICI
TY E-DIARY NOT CO
LLECTED FOR THIS S
UBJECTChanged
Information
Aug-19-2020
07:24:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENIC
ITY E-DIARY COLLE
CTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797925
Page 116 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-10-2020
14:13:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/10/2020Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797926
Page 117 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020
14:14:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/10/2020Initial Entry
2.a
Date Location User Value Reason
Sep-10-2020
14:14:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ident
ifier::1
Temperature
:36.8
Temperature
Unit:C
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-10-2020
14:14:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797927
Page 118 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Sep-10-2020
14:14:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-10-2020
14:14:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-10-2020
14:14:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797928
Page 119 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-10-2020
14:16:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-10-2020
14:16:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-10-2020
14:16:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/10/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797929
Page 120 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-10-2020
14:16:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-10-2020
14:16:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-10-2020
14:16:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-D
efined Ide
ntifier:113
Test:: Choriogona
dotropin Bet
a_PX113
Result::
Not Done:
:NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-10-2020 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797930
Page 121 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
14:16:17
(UTC-05:00)
Eastern Time (US &
Canada)(autocalc) 113
6.a Test:
Date Location User Value Reason
Sep-10-2020
14:16:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Bet
a_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-10-2020
14:16:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797931
Page 122 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020
14:16:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020
14:16:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020
17:33:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-10-2020
14:16:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797932
Page 123 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
review and
correct as
appropriate.
Sep-10-2020
14:16:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020
17:33:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP50S9Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020
17:33:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BP50S9Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797933
Page 124 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-10-2020
14:17:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020
14:17:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020
14:17:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020
14:17:27ACV0PFEINFP6000 Data Entry:
Sep/10/2020 12:18Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797934
Page 125 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020
14:17:27
(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-10-2020
14:17:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-10-2020
14:17:27
(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
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797935
Page 126 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-10-2020
14:17:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEC
IFIED OBSERVATION P
ERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-10-2020
14:17:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797936
Page 127 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-08-2020
13:12:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Oct/8/2020Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0797937
Page 128 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020
13:13:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020
13:13:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-09-2020
07:13:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-09-2020
03:36:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797938
Page 129 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
review and
correct as
appropriate.
Oct-08-2020
13:13:00
(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-08-2020
13:13:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/8/2020Initial Entry
5.a
Date Location User Value Reason
Oct-09-2020
07:13:13
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP511BInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-09-2020
07:13:13
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000 Data Entry:
BP511BInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797939
Page 130 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Canada)
5.b
Date Location User Value Reason
Oct-09-2020
07:13:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR85HInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-09-2020
07:13:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BPR85HInitial Entry
5.c
Date Location User Value Reason
Oct-09-2020
07:14:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR857Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797940
Page 131 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.c Sample ID
Date Location User Value Reason
Oct-09-2020
07:14:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BPR857Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797941
Page 132 of 156
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021
14:01:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/4/2021Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797942
Page 133 of 156
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-04-2021
14:02:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-04-2021
14:02:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-04-2021
14:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-04-2021
14:02:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797943
Page 134 of 156
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
review and
correct as
appropriate.
Mar-04-2021
14:02:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/4/2021Initial Entry
5.a
Date Location User Value Reason
Mar-04-2021
14:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRTCFFInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-04-2021
14:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRTCFFInitial Entry
5.b
Date Location User Value Reason
Mar-04-2021
14:03:01
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5WPDInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797944
Page 135 of 156
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)
5.b Sample ID
Date Location User Value Reason
Mar-04-2021
14:03:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP5WPDInitial Entry
5.c
Date Location User Value Reason
Mar-04-2021
14:03:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPNWM5Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-04-2021
14:03:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPNWM5Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797945
Page 136 of 156
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-08-2020
13:13:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Oct/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-08-2020
13:13:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-08-2020
13:13:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0797946
Page 137 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Sep-10-2020
17:20:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797947
Page 138 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Sep-10-2020
17:20:01
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-10-2020
17:20:01
(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
Sep-16-2020
17:31:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sigmoid diverticul
itisChanged
Information
Sep-16-2020
07:06:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed reported under
AER 2020357707
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797948
Page 139 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-15-2020
16:55:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answere
dForm has been
submitted, awaiting
confirmation of
receipt
Sep-15-2020
08:35:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued
:OpenedSAE RECON: As
confirmed with US
DSU, this was not
received on their
end. Please submit
an AEM form to
report event to
safety
Sep-14-2020
06:03:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued
:Candidatefor PSSR review
Sep-11-2020
18:16:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answere
dReport form faxed
this am.
Sep-11-2020
06:34:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
Diverticulitis(Onset
date:04Sep2020) is
not reported on
SAE Report Form
but marked serious
on AE CRF.
Confirm
seriousness and
report to Pfizer
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (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-2021-5683-0797949
Page 140 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
immediately. If this
event is not serious,
downgrade the
event on AE CRF
Sep-10-2020
17:21:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DiverticulitisChanged
Information
Sep-10-2020
17:20:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DiverticulosisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-10-2020
17:20:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-25-2020
12:30:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Response
satisfies query
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0797950
Page 141 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-25-2020
12:01:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/18/2020 00:0
0Changed
Information
Sep-25-2020
11:10:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New
Information
Sep-25-2020
11:10:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/25/2020 00:0
0New
Information
Sep-23-2020
16:35:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin:
Please confirm
if Sigmoid
diverticulitis is
still ongoing or
specify an end
date for this
condition.
Thanks
Sep-10-2020
17:20:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESChanged
Information
Sep-10-2020
17:20:01ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0797951
Page 142 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
6. Toxicity Grade:
Date Location User Value Reason
Sep-10-2020
17:21:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
3Initial 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
Nov-13-2020
13:29:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Closed Response
satisfies query
Nov-12-2020
07:05:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answered Updated SAE
report was just
faxed to DSU
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797952
Page 143 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-10-2020
20:13:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Opened Clinical No
information on
COVID testing
while in
Hospital
(Yes/No/unable
to get
information; if
Yes then
date/result) has
been submitted
to safety; this is
a request from
the independent
Data Monitoring
Committee,
please complete.
Oct-26-2020
22:43:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Query closed;
will follow for
SAE update on
requested
COVID test info
Oct-23-2020
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered Site will follow
up with subject
and submit
report
Oct-22-2020
23:27:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened Clinical -
COVID testing
has not been
reported in the
SAE submitted
to safety. Please
submit a
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797953
Page 144 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
follow-up SAE
form
(#2020357707]
to provide
whether COVID
testing was
performed
(yes/no) and if
yes, the results.
Sep-15-2020
08:36:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Deleted event missing in
SDB
Sep-10-2020
17:21:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
Diverticulitis:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Sep-10-2020
17:20:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
Diverticulosis:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797954
Page 145 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-10-2020
17:20:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious even
t associated with c
ongenital anomaly
or birth defect?
NO
Did this serious ev
ent result in death?
NO
Did this serious ev
ent require or prol
ong hospitalization
?
YES
Did this serious ev
ent result in persist
ent or significant d
isability/incapacity
?
NO
Is this serious even
t life threatening?
NO
Other medically i
mportant serious eInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797955
Page 146 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
vent
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.
Date Location User Value Reason
Sep-10-2020
17:20:01
(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
Sep-16-2020
17:46:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
Sigmoid diverti
culosisChanged
Information
Sep-10-2020
17:20:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797956
Page 147 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
OTHER
If Other, specify:
Diverticulosis
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-10-2020
17:20:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-10-2020
17:20:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-10-2020
17:20:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797957
Page 148 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Oct-01-2020
07:31:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedsafety database updated. issue
resolved
Sep-30-2020
16:57:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dOriginal value is correct
Sep-28-2020
05:28:29
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Op
enedSAE
RECON:AER#2020357707,outcome
was reported as
Recovering/Resolving to Safety DB
however, recorded as
ECOVERED/RESOLVED on AE
CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Sep-25-2020
11:10:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Clo
sedClose Auto Query
Sep-25-2020
11:10:48ACV0PFEINFP6000 Data
EntryNew Information
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797958
Page 149 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time
(US &
Canada):
REC
OVE
RED/
RESO
LVE
D
Sep-25-2020
11:10:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Op
enedFor AE Sigmoid diverticulitis:
Response to "What was the outcome
of this adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Sep-10-2020
17:20:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
REC
OVE
RING
/RES
OLVI
NGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-10-2020
17:20:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797959
Page 150 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Sep-16-2020
07:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2020357707Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797960
Page 151 of 156
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-26-2021
16:44:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797961
Page 152 of 156
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-26-2021
16:44:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to r
eturn for Vaccination 3
Participant is:
eligible and NOT con
firmed to have receiv
ed only placebo at Va
ccination 1/2Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797962
Page 153 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-26-2021
16:44:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-26-2021
16:44:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY
FOR ADDITIONAL VA
CCINATIONInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797963
Page 154 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-08-2020
13:13:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-19-2020
07:21:13
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMI
ZEDInitial Entry
Aug-19-2020
07:17:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-01-2020
19:00:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-30-2020
14:40:35
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Query 1: Answered A follow up
SAE report will
be sent by EOB
today
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797964
Page 155 of 156
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
& Canada)
Nov-25-2020
01:10:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL
Please submit
the Hospital
discharge date
for SAE
diverticulitis, in
a SAE
(#2020357707)
safety update
Oct-08-2020
13:13:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/8/2020Initial Entry
Aug-19-2020
07:21:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
Aug-19-2020
07:17:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797965
Page 156 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-12-2020
08:15:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae40c5\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797966